What are the responsibilities and job description for the Quality Assurance Inspector position at Tech Observer?
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
Salary : $35 - $38