Job Description

Job Responsibilities:

• The QA Investigation Reviewer is responsible for the independent review and approval of GMP investigations within the Andover biopharma manufacturing facility. This role ensures non-conformances/deviations, OOS/OOTs, and other quality events are thoroughly investigated, and compliant with cGMP regulations, site, and global procedures. The position supports product quality, patient safety, and timely batch disposition while partnering with cross-functional teams including Manufacturing, Engineering, and QC. The ideal candidate demonstrates strong critical thinking, clear written communication, and the ability to provide objective QA oversight, including support during regulatory inspections and audits.

Skills:

• Preferred 10 years of experience in quality assurance or inspection roles.
• Experience in Vault QMS a plus.

Education/Experience:

• Min. High school diploma or GED required, Associate or Bachelor’s degree preferred.

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