QA Investigation Reviewer

Job Title: QA Investigation Reviewer/ Quality Assurance Inspector

Location:
Andover, MA 01810

100% Onsite

Duration: 18 Month Contract

The QA Investigation Reviewer is responsible for the independent review and approval of GMP investigations within the Andover biopharma manufacturing facility. This role ensures that non-conformances/deviations, OOS/OOTs, and other quality events are thoroughly investigated and compliant with cGMP regulations, as well as 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, excellent written communication skills, and the ability to provide objective QA oversight, including support during regulatory inspections and audits.

• Independently review and approve GMP investigations.
• Review non-conformances/deviations, OOS/OOTs, and other quality events.
• Ensure investigations are thorough and compliant with cGMP regulations, site procedures, and global procedures.
• Support product quality, patient safety, and timely batch disposition.
• Collaborate with cross-functional teams, including Manufacturing, Engineering, and QC.
• Provide objective QA oversight throughout the investigation process.
• Support regulatory inspections and audits.

• The primary requirement for this role is hands‑on experience within the Quality function, specifically reviewing and approving GMP investigations.
• Priority should be given to candidates who can clearly demonstrate direct experience reviewing and approving quality investigations, rather than those with only general industry or quality backgrounds.

• High school diploma or GED required.
• Associate's or Bachelor's degree preferred.
• Minimum of 10 years of experience in Quality Assurance or inspection roles.
• Strong critical thinking and written communication skills.