Senior Operational Quality Specialist

About the Job

Title: Senior Operational Quality Specialist

Location: Boston, MA (Hybrid)

Employment Type: Contract

Status: Accepting Candidates

About the Role

We are seeking a Senior Operational Quality Specialist to provide quality oversight and support for GMP manufacturing operations within a regulated pharmaceutical environment. This role will be responsible for supporting batch record review, change control management, deviations, investigations, CAPAs, and quality compliance activities. The ideal candidate will have experience working closely with manufacturing teams to ensure adherence to GMP requirements while driving continuous improvement and operational excellence.

Key Responsibilities

• Provide quality support and oversight for GMP manufacturing operations.
• Support change control assessments, approvals, implementation, and closure activities.
• Review and approve deviations, investigations, root cause analyses, and CAPAs.
• Conduct GMP document reviews, including Master and Executed Batch Records.
• Maintain quality metrics and support timely product disposition activities.
• Identify quality risks and assist with mitigation strategies.
• Partner with cross-functional teams to ensure compliance with GMP requirements.
• Support continuous improvement and quality enhancement initiatives.

Qualifications

• Bachelor's degree in a scientific or related field.
• 2–5 years of GMP Quality Assurance or Operational Quality experience.
• Experience with batch record review in a pharmaceutical manufacturing environment.
• Knowledge of change controls, deviations, investigations, and CAPAs.
• Understanding of GMP/cGMP regulations and quality systems.
• Experience with small molecule manufacturing preferred.
• Veeva experience is a plus.

Compensation (MA Pay Transparency):

Estimated hourly range: $55–$60/hr (W-2).

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