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.
- Review and approve external manufacturing batch records.
- Track and organize documents for batch record closure.
- Organize external manufacturing documents.
- Track documents for localization distribution.
- Track OOS/deviation findings, report noticed trends to supervisor. Support company CAPA program.
- Assist in audit activities as required.
- Assist in review of external manufacturing procedures.
- Ensure all external manufacturing processes are covered in SOPs and WIDs and maintained in accordance with regulations.
- Assist in chemistry technology transfer and process validation activities.
- Support Project Management’s interactions with external manufacturing sites.
- Assist in assuring consistency between sponsor’s and external manufacturing sites’ quality agreements.
- Assist in updating External Manufacturing QA documents at appropriate review cycles.
- Maintain current documentation of training for external manufacturing sites.
- Keep current with industry guidelines and regulations.
- Other tasks as assigned by supervisor.
- Minimum of a Bachelor’s degree with 2-years’ experience in a comparable environment.
- Must be highly motivated and detail oriented.
- Biology or Chemistry background
Unique Department Requirements:
- Works in an environment with radiopharmaceuticals
- Due to location of manufacturing sites, there will need to be some flexible shift schedule 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.