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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United States

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.

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