• QA Associate II

    System One (Mahwah, NJ)


    Job Title: Quality Assurance Associate II

     

    Schedule: Tues- Saturday 2nd shift 4 PM- 12:30 AM (some flex needed)

     

    Type: Contract to Hire

    Must Haves:

    + BS or higher education degree in a scientifically related field

    + Experience in a biologics or biotechnology company (1-3 years)

    + Working knowledge and technical understanding of the aseptic manufacture of biologics preferred

    + Experience with batch record review in a biotechnology manufacturing environment.

    + Experience reviewing QC data in a biotechnology manufacturing environment

    + Working knowledge of GMP and TCTP regulations

    + Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)

    Responsibilities:

    + Under direct supervision, the associate supports daily tasks that are essential for maintaining and improving quality systems and adhering to client-specific procedures.

    + Key responsibilities include document management, review of manufacturing batch records, quality control (QC) data, facilitating material releases, overseeing final product releases, and providing essential assistance to the Quality Management as needed.

    + Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.

    + Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)

    + Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.

    + Release raw material in ERP system as well as on paper.

    + Perform Accessioning of incoming Apheresis.

    + Review Batch record and disposition material of finished product to client.

    + Provides information for Out of Specification and deviations to investigator.

    + Performs line clearance prior to manufacturing operations begins.

    + Supports tech transfer activities.

    + Other duties as assigned.

    + Build Quality into all aspects of your work by maintaining compliance to all quality requirements.

    + Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).

    + Attend all required Quality & Compliance training at the specified interval.

     

    Benefits

     

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

     

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.