Quality Assurance Specialist
Quality Assurance Specialist - Contract - Cambridge, MA
Proclinical is working alongside a pharmaceutical company seeking a Quality Assurance Specialist to join their team.
Primary Responsibilities:
The successful candidate will play a pivotal role in managing activities within a GMP-regulated environment, ensuring adherence to cGMPs and regulatory standards throughout the product development lifecycle. This position offers an exciting opportunity to work with cutting-edge cell therapies in the oncology sector.
Skills & Requirements:
- Bachelor's degree in biology, Microbiology, Chemistry, or related field.
- Experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy manufacturing.
- Knowledge of current GMP regulations in pharmaceuticals and cell/gene therapies.
- Understanding of Quality Management Systems and ability to make informed decisions.
- Local travel between manufacturing sites is required.
The Quality Assurance Specialist's responsibilities will be:
- Issue, review, and approve GMP documentation such as batch records and SOPs.
- Review and reconcile logbooks and documentation.
- Assist in walkthroughs with senior Quality staff.
- Review labeling and packaging batch records for release preparation.
- Evaluate work orders, equipment qualification, and validation documentation.
- Ensure compliance and accuracy in batch record documentation for drug substance/product release.
- Provide daily onsite quality oversight and guidance, collaborating across functions.
- Represent QA in operations from starting material thaw to product filling and labeling.
- Perform additional duties as assigned.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.