Quality Assurance Inspector

Job Title: QA Investigation Reviewer

Location: Andover, MA

Contract: 12 Months with a possibility of extension

Summary:

The QA Investigation Reviewer is responsible for the independent review and approval of GMP investigations within a biopharma manufacturing environment. This role ensures that deviations, non-conformances, OOS/OOT events, and other quality issues are thoroughly investigated and compliant with cGMP regulations, site procedures, and global standards. The position plays a key role in maintaining product quality, patient safety, and supporting timely batch release.

Key Responsibilities:

• Review and approve GMP investigations including deviations, OOS/OOTs, and non-conformances
• Ensure investigations are thorough, compliant, and completed within timelines
• Provide independent QA oversight and ensure adherence to cGMP and regulatory requirements
• Collaborate with cross-functional teams including Manufacturing, QC, and Engineering
• Identify gaps, trends, and recommend corrective and preventive actions (CAPA)
• Support batch disposition decisions by ensuring investigation quality and completeness
• Participate in regulatory inspections and internal/external audits
• Ensure proper documentation, data integrity, and quality standards are maintained

Required Skills:

• Strong knowledge of cGMP and regulatory compliance
• Excellent analytical and critical thinking skills
• Strong written and verbal communication
• Attention to detail and ability to review complex investigations
• Ability to work cross-functionally in a fast-paced environment

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 in a GMP environment
• Experience with quality systems (e.g., Vault QMS) is a plus