GMP Quality Specialist

Job Description

Job Description

A biopharmaceutical organization is looking to connect with experienced Quality Assurance professionals with GMP manufacturing experience for an opportunity supporting quality and compliance activities within a regulated manufacturing environment. The ideal candidate will have hands-on experience with deviations, investigations, CAPAs, change controls, batch record review, and GMP compliance. Candidates who began their careers in analytical testing, laboratory operations, or analytical development before moving into Quality are especially encouraged to apply.

Responsibilities

• Provide Quality support and oversight for GMP manufacturing activities.
• Partner with Manufacturing, Quality Control, Operations, and other technical groups on quality-related matters.
• Review quality events, including deviations, investigations, and out-of-specification results.
• Evaluate root cause analyses and proposed corrective and preventive actions.
• Review and approve CAPAs and change controls.
• Assess potential quality and product impact associated with manufacturing events.
• Review GMP documentation and manufacturing records for compliance and completeness.
• Support product release and disposition activities.
• Identify quality risks and contribute to risk mitigation strategies.
• Monitor quality metrics and support timely completion of quality deliverables.
• Participate in audit activities and support remediation efforts.
• Identify opportunities to improve quality systems, processes, and manufacturing practices.
• Collaborate with internal stakeholders and external partners as needed.

Qualifications

• Bachelor's degree in a scientific, technical, or related discipline.
• 4+ years of relevant experience in pharmaceutical or biopharmaceutical Quality.
• Experience working within a GMP manufacturing environment.
• Strong experience with deviations, investigations, root cause analysis, CAPAs, change controls, GMP documentation review
• Understanding of pharmaceutical cGMP requirements.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Strong problem-solving and analytical skills.

Preferred Experience

• Commercial manufacturing or product release experience.
• Pharmaceutical manufacturing experience.
• Experience with drug substance or drug product operations.
• Experience with solid-dose pharmaceutical manufacturing is a plus.
• Prior analytical laboratory, analytical testing, or analytical development experience is highly valued.
• Experience working with external manufacturing or supply partners is a plus.

If you have a background in GMP Quality Assurance, manufacturing quality, investigations, CAPA, deviations, or pharmaceutical compliance, we'd be interested in connecting with you.

Must be willing to commute to Boston Pandologic. Keywords: Quality Control / Quality Assurance Specialist, Location: Cambridge, MA - 02238 , PL: 604161302