Careers

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Research Associate II

Purpose: Associates of Cape Cod, Inc. (ACC) is a global leader in endotoxin and (1?3)-ß-D-glucan detection products and services. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.

We are seeking a talented collaborative, and driven Research Associate II to join the Research and Development team. They will work to support the development of new products that meet ACC corporate sustainability goals using current and new technology.

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the research and development pipeline through growth and maintenance of cells utilizing aseptic techniques. It requires performing various cell culture procedures like cell passaging, media preparation, transfection, and cell viability assays in a laboratory setting. The work also involves record-keeping, troubleshooting technical issues, and ensuring compliance with relevant safety and regulatory standards. This role may require supervision of junior members to provide adequate training.

Knowledge and Skill Requirements:

Bioprocess pipeline experience covering upstream and downstream processes and scale-up to 2000L
Prior experience developing and maintaining new bioprocesses for the expression of protein in various cell lines and tissue culture methods for both adherent and suspension cells
Prior experience developing and maintaining an organized bioprocess laboratory
Track record in implementing and integrating novel cell culture technology
Ability to organize data, analyze results, write technical reports, make data driven decision and draft protocols
Experience working within a quality system e.g. knowledge of cGMP, ISO 13485
Project management
Experience working as part of a cross functional team
Experience collaborating with external CRO/CMOs
Experience with change management processes

Education and Experience:

Bachelor’s degree in Cell Biology, Chemical Engineering, Bioprocess Engineering or related discipline with a minimum of 3-4 years of cell culture experience is required
Master’s degree and 5+ years of relevant cell culture experience are preferred

General Competencies:

Excellent written and verbal communication skills required
Strong record keeping and organizational skills with excellent attention to detail
Ability to work independently with minimal supervision
High level of computer literacy expected
Good listener, committed to finding solutions to problems, works well with difficult people
Works well with internal and external team members, promotes a positive image of the company, and strives to solve issues
Able to reach fact-based decisions, takes a thoughtful approach when considering options, seeks input from others, makes difficult decisions

Physical Requirements:

Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms, climb or balance. Occasionally stoop, kneel, crouch, or crawl. Must be able to hear and communicate verbally. Lift 11- 25 lbs. 30-60% of the time. Carry 11 -25lbs 30-60%. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Frequently exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Ability to type using a computer keyboard is required. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gown, and facemasks is required.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Bachelor’s/Master’s degree here.

In your cover letter please answer the following:

Have you completed the following level of education: BS/MS in biochemistry, chemistry, analytical chemistry, or closely related field?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Facility Engineer

Purpose: Design and implement facility engineering projects in support of overall corporate objectives.

General Responsibilities:

Responsible for the design and implementation of facility engineering projects including HVAC, production equipment, building management system and capital expense projects
Provide expertise in research, manufacturing, engineering, design and process design/scale-up
Assist the manufacturing/research operations in problem solving with regard to equipment and systems
Develop capital expenditure requirements and documentation to purchase/install new systems/equipment/processes
Develop and recommend new processes and technologies to achieve cost effectiveness and improved product quality
Recommend processes for the production of products
Interface with various departments (specifically manufacturing and engineering) to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology
Support company growth with space optimization and construction management for manufacturing, research and administrative areas
Maintain the facility drawings and ensure that applicable drawings follow change control for any modifications
Provide assistance with annual reporting to regulatory agencies
Perform other duties as assigned by the supervisor

Knowledge and Skill Requirements:

Knowledge of HVAC, chilled water systems, pure water systems
Knowledge of production equipment including autoclaves, depyrogenation ovens, filling equipment, lyophilizers, capping and labeling equipment
Project management/team leader skills
cGMP and ISO requirements for clean room operations

Education and Experience:

A minimum of a Bachelor's degree in an engineering discipline or an equivalent combination of experience and/or education required
Minimum of 5 years' experience in a manufacturing environment
Proficient with AutoCAD
Hands on experience with facility and production equipment including preventive maintenance and troubleshooting and resolving equipment problems

General Competencies:

Adapts to change, open to new ideas and responsibilities
Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
Information organized and accessible, maintains efficient work space, manages time well. Manages workload, works efficiently, and meets goals and objectives
Manages workload, works efficiently, and meets goals and objectives
Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently sit. Occasionally stand and sit. Frequently use hands. Occasionally reach with hands or arms. Frequently talk or listen
Lift 11-25 lbs. 1-33% of the time. Carry 11-25lbs. 1-33% of the time. The work environment of this job is quiet

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Facility Engineer here.

In your cover letter please answer the following:

Have you completed the following level of education: Bachelor's degree in an engineering discipline or an equivalent?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Sr. Research Scientist

Purpose: To develop a greater scientific understanding of the ACC/SKK product line and effect changes in protocols to give greater reliability with respect to products. To develop new products revolving around the current technology and new concepts leading to new technologies.

General Responsibilities:

Adapt and develop new technologies around the LAL system
Develop projects that will enhance the scientific understanding of the current products with the goal of improvement and the introduction of new products
Expand the range of products within the framework of ACC
Provide the technical expertise to conceptualize and implement new research areas
Provide technical support when necessary
Supervise Research and Development staff

Knowledge and Skill Requirements:

Protein Chemistry/Biochemistry including enzymology and purification
The use of spectroscopic, chromatographic and molecular biological techniques
Assay Development
Technology transfer and scale-up
Supervisory experience

Education and Experience:

A minimum of a PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience and/or education required
Several years of experience in assay development, protein chemistry and protein purification
Additional expertise in Molecular Biology and supervisor/management experience is desired

General Competencies:

Adapts to change, open to new ideas and responsibilities
Uses resources efficiently, strives to reduce cost, part of the budgeting process
Communicates well (written and verbal), delivers presentations, has good listening skills
Perform task with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
Good listener, committed to finding solutions to problems, works well with difficult people
Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers
Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions

Physical Requirements:

Frequently sit, frequently stand and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Occasionally taste or smell. Lift 11 – 25 lbs 34-66% of the time. Carry 11 – 25 lbs 34-66% of the time. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Frequently exposed to fumes or airborne particles, frequently exposed to toxic or caustic chemicals. Occasionally exposed to uneven surface and vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Sr. Research Scientist here.

In your cover letter please answer the following:

Have you completed the following level of education: A minimum of a PhD in Chemistry, Biochemistry or related field ?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Temporary Laboratory Technician

Purpose: Associates of Cape Cod, Inc. seeks full-time temporary workers to collect and process blood cells from horseshoe crabs to make LAL - a test for a bacterial toxin. Applicants must be hard working, careful, team players with a positive attitude. Work will last from approximately May - Mid August with a limited number of positions going into the holidays. Perfect for students or others seeking experience in the biotech field. Must be 18+ to be considered. Responsible for all functions related to Horseshoe Crab bleeding and processing.

General Responsibilities:

Receiving crabs and unloading barrels of crabs from trucks
Bleeding crabs, initial cell processing, and operation of centrifuges
Washing and preparing all bleed related glassware
Assisting with preparation of Production glassware
Cleaning all bleed related rooms
Other duties as assigned by supervisor

Knowledge and Skill Requirements:

English language skills
Able to lift up to 25 lbs.

Education and Experience:

Minimum of 3 years of high school, or more; 1 yr. of college preferred or an equivalent combination of experience and/or education required.

General Competencies:

Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Honest, accountable, maintains confidentiality
Information is organized and accessible, maintains efficient workspace, manages time well
Manages workload, works efficiently, and meets goals and objectives
Strives to eliminate errors, accurate work is a priority, seeks opportunities, to improve product/services, compliant with quality system requirements
Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

Occasionally sit. Constantly stand, frequently walk. Constantly use hands to finger, handle or feel.
Frequently reach with hands or arms. Occasionally climb or balance. Constantly talk or hear. Occasionally taste or smell. Lift 26 to 50 lbs, 1-33% of the time. Carry 11-25 lbs, 1-33% of the time. Occasionally exposed to wet or humid conditions (non-weather). Occasionally work near moving mechanical parts. Frequently exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Temporary Laboratory Technician here.

In your cover letter please answer the following:

Have you completed the following level of education: High School diploma or equivalent?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Logistics Technician/Labeling

Purpose: Work as part of a team where needed, with primary focus within the Labeling Department on labeling of product, packaging final product for sale, and controlling of inventory in the Work-in-Process warehouses.

General Responsibilities:

Labeling;
- Primary duties are in the labeling department where this includes:
  - Labeling finished products as well as in-process materials using labeling machines or by hand as required
  - Generating packaging labels and miscellaneous labels as required
  - All necessary DMS transactions for the above labeling processes
- Assure that all labeling processes are carried out in a cGMP manner following all quality system requirements
- Assisting in monthly cycle counts in all areas
- Absentee coverage in labeling and kitting/packaging
Kitting/Packaging;
- Assists Kitting Department as needed, in the assembly and packaging of finished product to be sold to customers
- Assists Kitting Department with shrink-wrapping of finished packaging products using a shrink-wrapping machine
- All necessary DMS transactions for the above packaging processes

Knowledge and Skill Requirements:

Ability to accurately follow procedures
Requires attention to detail
Ability to work alone and as part of a team
Excellent mechanical skills and care with machinery
Excellent communication skills
Possess time-management skills
Intermediate computer skills
Excellent attention to detail and ability to maintain organized, accurate, and complete records
Valid driver's license

Education and Experience:

High school diploma or equivalent
1-plus year of labeling experience in a GMP/ISO environment is preferred

General Competencies:

Strives to eliminate errors, accurate work is a priority
Compliant with quality system requirements
Ability to be flexible and shift direction easily
Ability to take direction and prioritize assigned tasks
Close interaction with a wide range of personalities

Physical Requirements:

Sit occasionally
Constantly stand, walk, and use hands to finger, handle, or feel
Constantly reach with hands or arms, occasionally climb or balance, occasionally stoop, kneel, crouch, or crawl, talk or listen, occasionally smell
Constantly looking at detailed printed information
Lift 11 - 25 lbs 67-100% of the time, carry 26-50 lbs 1-33% of the time
Constantly work near moving mechanical parts, occasionally work in high places, and occasionally work in extreme cold (non-weather) environment
Frequent moderate noise is typical for the work environment of this job

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Logistics Technician/Labeling here.

In your cover letter please answer the following:

Have you completed the following level of education: High School Diploma or equivalent?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Boiler Operator

Purpose: To maintain and monitor boiler and building systems in accordance with Massachusetts laws.

General Responsibilities:

Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations. CMR-146. This includes standing watch in a 24/7 environment on either a fixed or rotating schedule
Make rounds every two hours of the mechanical room and the air handling room, checking for any problems with the machinery
Performing preventive maintenance on facility equipment and production equipment as needed and in accordance with FDA and cGMP guidelines
Troubleshoot any problems and take corrective actions for machinery, water systems and production equipment throughout the building
Answer and troubleshoot alarms from the Building Management System
Take water samples of the clean steam system, DPW system, and take TOC readings on the DI and Clean Steam System
All duties assigned by supervisor

Knowledge and Skill Requirements:

Knowledge of High Pressure Boiler Systems
Knowledge of DI and DPW water systems
Knowledge of HVAC Systems
Ability to follow written and verbal instructions
Working knowledge of cGMP, ISO 13485 and other regulatory guidelines as appropriate

Education and Experience:

Minimum of a High School Diploma or equivalent education and/or experience required
Second class fireman’s license or greater (required)

General Competencies:

Adapts to change, open to new ideas and responsibilities
Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
Information organized and accessible, maintains efficient work space, manages time well
Manages workload, works efficiently, and meets goals and objectives
Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Occasionally sit. Frequently stand and walk. Frequently use hands. Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Occasionally talk or listen. Lift 26-50 lbs. 1-33% of the time. Carry 26-50 lbs. 1-33% of the time.

Frequently exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally work in high places, occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions, extreme heat (non-weather). Work environment is loud for this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Boiler Operator here.

In your cover letter please answer the following:

Have you completed the following level of education: High School Diploma or equivalent education?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Quality Control Analyst II

Purpose: Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Results are compared to specifications and documented. Analyst has mastered most or all of the fundamental quality control concepts as well as some specialized technologies and receives minimal supervision on routine assignments. Analyzes and interprets test results independently and contributes to design of new studies in consultation with Supervisor. May provide guidance and training to more junior staff members.

General Responsibilities:

Technical Expertise
- Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
  - Proficiency is defined in the individual performance objectives,
  - Test methods may include (but are not limited to):
    - Environmental Monitoring
      - Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
      - Perform Growth Promotion testing of microbiological media
      - Perform Plate reading, streaking, gram staining, and microbial ID
      - Perform Sterility Testing
    - Product Release and Stability Testing
      - Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP's
      - Perform testing of samples with increasing complexity in accordance with written protocols
      - Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
      - Performs Karl Fisher titration for moisture
      - Performs pH determination
      - Performs container closure testing
      - Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
      - Prepares and reviews Certificates of Analysis
      - Formulates and tests in process solutions to determine final product ratios
  - Data Analysis
    - Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete
  - General Lab Support
    - Test sample management and handling, maintenance of lab equipment and log books, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
    - Participate in safety, customer, and quality audits including answering questions during tours
    - Maintain log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
Problem Solving/Decision Making
- - Analyze and interpret study investigation results in conjunction with Supervisor. Work with Supervisor to propose next steps. Propose corrective actions in response to assay and/or instrument problems to Supervisor for review prior to implementation.
  - Contribute to and when assigned lead discussions with the team (either in or out of lab meeting) to meet group goals
  - Communicates interdepartmentally and with outside contacts to solve technical issues as directed by Supervisor
  - When conducting testing, if SOP's or test methods (e.g. Method of measuring pH) are not optimal, propose ideas for development and optimization in order improve compliance, efficiency and/or reduce cost (e.g. Align current procedures with current practices, consolidate forms or procedures, recommend purchase of new equipment or instrument to upgrade or replace obsolete model). Present idea to Supervisor for approval.
  - Begins to utilize colleagues and literature to solve complex problems
  - Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and methodology problems. Alert Supervisor and make detailed observations in support of investigations.
  - Review departmental paperwork/data for compliance to procedures and specifications, identifying trends, aberrant results and potential cGMP violations to assist department as needed.
Planning
- - Plans sequencing of individual (or group as needed) tests and activities and communicate plan to Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (e.g. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
  - Prepare reports independently and submit to Supervisor for review. Collaborate with Supervisor to incorporate changes/revisions as necessary in order to generate a complete report that will be ready for upper management review.
Supervision
- - Receives overall direction from Supervisor and carries out test without supervision.
  - No formal supervisory responsibility
  - May provide training to other staff members
Perform other additional job related duties as required

Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

Knowledge and Skill Requirements:

Organizational skills
General laboratory skills
Must be detailed oriented and show proficiency in aseptic and laboratory technique
Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
Required to pass a pipetting proficiency training and certification course

Education and Experience:

A minimum of a B.S. degree in a relevant scientific discipline w/ 2-4+ years of laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.
M.S. degree preferred in a relevant scientific discipline w/ 0-2+ years of laboratory experience within a cGMP regulated environment.

General Competencies:

Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Information organized and accessible, maintains efficient work space, manages time well
Manages workload, works efficiently, and meets goals and objectives
Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms. Frequently climb or balance. Frequently stoop, kneel. Must be able to hear and communicate verbally. Lift > 25 lbs. 10% of the time above shoulder. Carry 1-10 lbs. frequently above shoulder. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Fine motor skills and dexterity are required in order to pipette small volumes (need a steady hand).Ability to type using a computer keyboard is required. Personnel cannot have a skin condition, upper respiratory illness, or allergic reaction that causes excessive sneezing, itching, or scratching. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gown, and facemasks is required.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Quality Control Analyst II here.

In your cover letter please answer the following:

Have you completed the following level of education: Bachelor of Science degree?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Quality Control Analyst III

Purpose: Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Results are compared to specifications and documented. Analyst is technically independent and has mastered fundamental quality control concepts as well as some specialized technologies. Independently coordinates activities with others both inside QC and outside the department and carries out projects with minimal supervision. Displays initiative and technical commitment and independence for study design. Organizes and provides written and/or oral presentations of work with minimal input from Supervisor. Displays ability to perform more complex studies and to make independent contributions to the development of new technologies. Provides guidance and training to other staff members.

General Responsibilities:

Technical Expertise
- Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
  - Test methods may include (but are not limited to):
    - Environmental Monitoring
      - Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
      - Perform Growth Promotion testing of microbiological media
      - Perform Plate reading, streaking, gram staining, and microbial ID
      - Perform Sterility Testing
    - Product Release and Stability Testing
      - Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP's
      - Perform complex testing in accordance with written protocols
      - Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
      - Performs Karl Fisher titration for moisture
      - Performs pH determination
      - Performs container closure testing
      - Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
      - Prepares and reviews Certificates of Analysis
      - Formulates and tests feasibilities for final product ratios
  - Data Analysis
    - Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete.
  - General Lab Support
    - Test sample management and handling, maintenance of lab equipment and log books, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
    - Participate in safety, customer, and quality audits including answering questions during tours
    - Maintain and review log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
    - May be responsible for coordination of intra and/or interdepartmental activities
    - Participate in safety, customer, and quality audits including answering questions during tours and providing written responses to audit findings as assigned
Problem Solving/ Decision Making
- - Technically independent and contributes substantially to the interpretation of results and design of follow up studies. Propose next steps to Supervisor for approval prior to execution. Propose corrective actions in response to assay and/or instrument problems to Supervisor for review prior to implementation
  - Contribute to and when assigned lead discussions with the team (either in or out of lab meeting) to meet group goals
  - Independently communicates interdepartmentally and with outside contacts to solve technical issues and communicates results to Supervisor
  - Proactively investigate and troubleshoot Quality Control Methods and SOP's to improve compliance, efficiency and/or reduce cost (e.g. recommend purchase of new equipment or instrument to upgrade or replace obsolete model, identify new alternative methodology/technologies , performing gap analysis to ensure alignment with cGMP or regulatory guidance's) . Present idea to Supervisor for approval
  - Utilize colleagues and literature to solve complex problems
  - Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and methodology problems. Alert Supervisor and make detailed observations in support of investigations
  - Review departmental paperwork/data for compliance to procedures and specifications, identifying trends, aberrant results and potential cGMP violations to assist department as needed
  - Represent QC at cross functional meetings as assigned in a leadership capacity (this includes disseminating information in a professional manner with the groups goals represented)
Planning
- - Plans sequencing of individual (or group as needed) tests and activities and communicate plan to Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (e.g. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
  - Prepare reports independently and submit to Supervisor for approval. Reports should be ready for upper management review at time of submission to Supervisor
  - Prepare metrics reports including statistical analysis of results when required
  - Prepare training plans when required
Supervision
- - Receives overall direction from Supervisor and carries out test without supervision.
  - May supervise junior staff members
  - Provides training of other staff members
Perform other additional job related duties as required

Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

Knowledge and Skill Requirements:

Organizational skills
General laboratory skills
Must be detailed oriented and show proficiency in aseptic and laboratory technique
Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
Required to pass a pipetting proficiency training and certification course

Education and Experience:

A minimum of a B.S. degree in a relevant scientific discipline w/ 4-6+ years of laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.
M.S. degree preferred in a relevant scientific discipline w/ 4+ years of laboratory experience within a cGMP regulated environment.

General Competencies:

Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Information organized and accessible, maintains efficient work space, manages time well
Manages workload, works efficiently, and meets goals and objectives
Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Quality Control Analyst III here.

In your cover letter please answer the following:

Have you completed the following level of education: Bachelor of Science degree?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Logistics Technician 1

Purpose: Work as part of a team where needed, controlling of inventory in the Finished goods and Raw material warehouses, receiving incoming packages/shipments, labeling of product, packaging final product for sale, and fulfillment of customers’ orders.

General Responsibilities:

Shipping;
- Fulfillment of all Customers orders
- Preparation of all outgoing shipments including documentation for those shipments
- Control of all “Finished Released” product
Receiving;
- Receives/stores all materials for ACC use
- Performs all necessary receiving transaction within Data Management System (DMS). Confirms accuracy of receipt against ACC documentation/Purchase Order
- Receipt of Testing Services samples
- Fulfills and completes transactions of all raw material in-house material requisitions
Kitting/packaging;
- Assists Kitting Department as needed, in the manufacturing/packaging of finished product to be sold to customers
- All necessary DMS transactions for the above packaging process
- Labeling;
- Assists in the labeling department as needed, labeling finished products as well as in-process material
- In addition to the tasks, assisting in weekly cycle counts in all areas
- Absentee coverage in all areas

Knowledge and Skill Requirements:

Valid driver’s license
Detail oriented
Strong organizational skills
Good communications skills
Working computer knowledge

Education and Experience:

High school diploma or equivalent
Working in a high paced deadline environment
Close interaction with a wide range of personalities

General Competencies:

Able to work independently or as part of a team within a fast paced deadline environment
Ability to multitask
Ability to be flexible and shift direction easily
Ability to prioritize

Physical Requirements:

Ability to lift at least 25 lbs
Ability to do repetitive jobs/movements
Ability to work on your feet for extended periods of time

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Logistics Technician 1 here.

In your cover letter please answer the following:

Have you completed the following level of education: High School Diploma or equivalent?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.

Customer Service Representative

Purpose: The Customer Service Representative (CSR) is responsible for interacting with customers via the phone to process orders for products and services for worldwide distribution. This position requires excellent interpersonal and communication skills, a command of the ACC ordering system and an in depth knowledge of the products and their uses. The CSR needs to be comfortable with speaking with customers to build rapport, and be able to resolve minor disputes amiably so as to retain the customer’s loyalty to ACC.

General Responsibilities:

Process customer orders via fax, phone and email
Provide inventory alerts to manufacturing
Support sales by providing literature, forwarding sales leads, coordinating technical support
Perform workshop registration
Invoicing for all services and billing for orders
Process orders
Maintain and Manager customer database and files
Issue return authorizations
Initiate complaint forms

Knowledge and Skill Requirements:

Data entry skills
Excellent verbal communication skills
Self starter, highly motivated with the ability to multi task in a fast paced environment
Willing to learn new technologies
Microsoft Excel, Word
Knowledge of ACC products

Education and Experience:

Must have 3-5 years Customer Service experience preferably in a GMP/ISO product environment
Must have a minimum of a High School diploma or equivalent

General Competencies:

Communicates well (written and verbal), delivers presentations, has good listening skills
Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (power point). The level of proficiency is defined by the requirements of the position held
Good listener, committed to finding solutions to problems, works well with difficult people
Works well with internal and external customers, promotes a positive image of the company, strives to solve issues raised by customers
Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Honest, accountable, maintains confidentiality
Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
Takes action, seeks new opportunities, strives to see projects to completion within the boundaries of the job description
Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
Information organized and accessible, maintains efficient work space, manages time well
Manages workload, works efficiently, and meets goals and objectives
Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
Meets deadlines, establishes appropriate priority, gets the job done in a timely manner
Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

Constantly sit, frequently stand and walk. Constantly use hands to finger, handle, or feel. Constantly reach with hands or arms. Occcasionally stoop, kneel, crouch, or crawl. Constantly talk or hear. Lift 1-10 lbs 1-33% of the time. Carry 1-10 lbs, 1-33% of the time. Work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Customer Service Representative here.

In your cover letter please answer the following:

Have you completed the following level of education: High School diploma or equivalent?
Are you authorized to work in the United States?
Must be willing to undergo a background check after an employment offer has been made.