QA Specialist - Investigations

Title: Senior Staff Manufacturing Technical Operations (MTO)

Location: Boston, MA (On-site)

Employment Type: Contract (12+ months expected)

Status: Accepting Candidates

About the role

Support manufacturing quality operations by leading investigations, managing quality records, and driving GMP compliance initiatives.

Key Responsibilities

• Triage and support manufacturing issues in real time on the production floor.

• Lead investigations, root cause analysis, and documentation for deviations, CAPAs, and quality events.

• Manage change controls, risk assessments, effectiveness checks, and eQMS records through closure.

• Collaborate with SMEs and cross-functional teams to implement corrective and preventive actions.

• Promote compliance best practices and support continuous improvement initiatives within manufacturing operations.

• Ensure timely completion of quality records while supporting operational priorities and manufacturing timelines.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical discipline.

• 6+ years of progressive experience in pharmaceutical manufacturing or development within a GMP-regulated environment.

• Strong experience leading investigations, root cause analysis, CAPAs, and deviation management.

• Experience supporting manufacturing floor operations and working within controlled environments.

• Excellent technical writing, organizational, and communication skills.

• Ability to manage multiple priorities and collaborate effectively across functional teams.

• Experience with eQMS systems and compliance documentation preferred.

Compensation (MA Pay Transparency):

Estimated hourly range: $50–$56/hr (W-2).

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