Quality Systems & Investigations Specialist

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).

• • Final rate within this range will be based on skills, experience, and interview results.