Quality Control Investigations Specialist

Job Description

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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