Quality Assurance Inspector

Job Title: QA Investigation ReviewerLocation: Andover, MAContract: 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-conformancesEnsure investigations are thorough, compliant, and completed within timelinesProvide independent QA oversight and ensure adherence to cGMP and regulatory requirementsCollaborate with cross-functional teams including Manufacturing, QC, and EngineeringIdentify gaps, trends, and recommend corrective and preventive actions (CAPA)Support batch disposition decisions by ensuring investigation quality and completenessParticipate in regulatory inspections and internal/external auditsEnsure proper documentation, data integrity, and quality standards are maintainedRequired Skills:Strong knowledge of cGMP and regulatory complianceExcellent analytical and critical thinking skillsStrong written and verbal communicationAttention to detail and ability to review complex investigationsAbility to work cross-functionally in a fast-paced environmentEducation & Experience:High school diploma or GED required; Associate or Bachelor’s degree preferred5–7 years of experience in Quality Assurance or inspection roles in a GMP environmentExperience with quality systems (e.g., Vault QMS) is a plus