Quality Assurance Inspector
Tech Observer, Andover, MA, United States
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
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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
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