Title: QC Investigations Specialist
Location: Greater Boston Area, MA (Onsite)
Employment Type: Contract
Status: Accepting Candidates
About the role
This role supports real-time manufacturing operations by leading investigations, resolving on-floor issues, and ensuring high-quality documentation. You’ll partner closely with manufacturing, QC, materials, and facilities teams to maintain operational continuity and compliance.
Key Responsibilities
• Triage manufacturing issues and lead analytical investigations and root cause analysis .
• Write clear, compliant quality documentation including deviations and CAPAs.
• Coordinate with SMEs to determine immediate actions, containment, and impact assessments.
• Interpret data to support structured problem-solving and continuous improvement.
• Provide technical operations support across manufacturing and QC functions.
Qualifications
• 6+ years pharmaceutical or biotech manufacturing experience.
• 4+ years analytical investigation and QC-focused experience.
• Strong background in RCA, deviation management, and GxP documentation .
• Ability to interpret analytical data and think scientifically under time-sensitive conditions.
• Experience partnering cross-functionally with manufacturing, QC, materials, and facilities teams.
Compensation (MA Pay Transparency):
• Estimated hourly range: $50–$55/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.
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