Purpose of the position/Job Summary:
The QA Associate-Chemistry (External Manufacturing QA) is responsible for performing various QA analyses on company products, ensuring the quality and integrity of the finished product, production/QC data in support of CMC and other FDA submission documents.
Scope & Impact:
This individual will work closely with Regulatory Affairs and the Chemistry groups to enhance quality systems and methods for documentation of the adherence to company procedures, Good Clinical Practice, Good Manufacturing Practice, 21CFR Part 212 and other regulatory requirements. The incumbent will also interact with external site manufacturing personnel. Research involving human participants, and the development and use of radio-pharmaceuticals, requires the timely and precise organization of regulatory documents. It is imperative that regulatory documentation reflect the changing requirements of regulations and Invicro’s interpretation of those changes. This position will help ensure that all chemistry products (External Manufacturing) for human use are safe and of high quality.
Major responsibilities:
Qualifications:
Required:
Preferred:
Unique Department Requirements:
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.
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