QA Investigation Reviewer

Job Description

Job Summary:

• 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.

Education/Experience:

• High school diploma or GED required; associate or bachelor’s degree preferred 5-7 years of experience in quality assurance or inspection roles.
• Experience in Vault QMS a plus.