Tech Observer · 1 day ago
Quality Assurance Investigator
Andover, MA
Contract
Onsite
Senior Level
$30/hr - $37/hr
5+ years expTech Observer is a company focused on biopharma manufacturing, and they are seeking a Quality Assurance Investigator to ensure compliance with cGMP regulations and support product quality. The role involves independent review and approval of GMP investigations and providing QA oversight across manufacturing operations.
BiotechnologyLife SciencePharmaceutical
Hiring Manager
Brian Joel
Responsibilities
Independently review and approve GMP investigations, including deviations, non-conformances, OOS/OOTs, and quality events
Ensure investigations are thorough, scientifically sound, and compliant with cGMP and internal procedures
Partner with Manufacturing, Engineering, QC, and other cross-functional teams to support investigations and corrective actions
Support timely batch release and product disposition activities
Provide QA oversight during regulatory inspections, audits, and internal reviews
Ensure clear, concise, and compliant documentation within quality systems
Qualification
Required
High School Diploma or GED required
5–7 years of experience in Quality Assurance, GMP compliance, or inspection roles within a regulated environment
Strong understanding of cGMP regulations and quality systems
Excellent critical thinking, written communication, and decision-making skills
Preferred
Associate's or Bachelor's degree preferred
Experience with Vault QMS is a plus
Company
Tech Observer
Tech Observer is a pharmaceuticals company that offers clinical research and analytical support services.
201-500 employees
H1B Sponsorship
Tech Observer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (12)
2023 (7)
2022 (25)
2021 (12)
2020 (29)
Funding
Current Stage
Growth StageLeadership Team
♚ Amit Krishnatry
CEO
Company data provided by crunchbase