Title: Quality Systems & Investigations Specialist
Location: Greater Boston Area, MA (Onsite)
Employment Type: Contract
Status: Accepting Candidates
About the role
This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams.
Key Responsibilities
• Lead real-time floor support, triaging deviations and initiating root cause investigations .
• Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments.
• Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions.
• Apply structured scientific thinking to evaluate data and support operational decisions.
• Contribute to process improvement by identifying trends and proposing optimized workflows.
Qualifications
• 6+ years experience in pharma/biotech manufacturing environments.
• Proven background in investigations, RCA, QC analytics, and GxP documentation .
• Skilled in cross-functional coordination and rapid issue assessment.
• Strong analytical mindset with the ability to interpret complex data sets.
• Experience supporting manufacturing operations in fast-paced, regulated environments.
Compensation (MA Pay Transparency):
• Estimated hourly range: $50–$58/hr (W-2).
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