Senior Quality Assurance Specialist I (Swing Shift) PC 1606

Miltenyi Biomedicine • Gaithersburg, MD

30d • $110,026 - $119,719

About The Position

This position is primarily responsible to supports QA on-the-floor manufacturing
activities, batch record review, and quality system processes to ensure
operations are conducted in accordance with current Good Manufacturing Practices
(cGMP). The position requires the ability to support swing shift manufacturing
operations and occasional weekend work.

Requirements

• Bachelor’s degree in Biology, Microbiology, Biotechnology, Chemistry, or related life sciences field. A minimum of 5 years’ of Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Strong experience with QA on-the-floor support and batch record review.
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements; Clear understanding of standards of practice used in the manufacture of biotechnology products
• Experience in cell therapy products effectively supporting FDA inspections, EU regulators and client audits.
• Ability to work a swing shift schedule.

Responsibilities

• Provide QA on-the-floor oversight during swing shift GMP manufacturing operations, ensuring adherence to approved procedures, batch records, and regulatory requirements.
• Perform review of batch production records, logbooks, and supporting documentation to ensure completeness, accuracy, and compliance prior to QA approval.
• Support real-time manufacturing activities, including line clearance verification, material verification, equipment status checks, and monitoring of critical process steps.
• Author, review, and revise relevant documentation, such as SOPs, Policies and Standards related to GMP compliance requirements.
• Identify and report quality issues, deviations, and compliance risks during manufacturing operations.
• Participate in deviation investigations, assist with root cause analysis, and support implementation of Corrective and Preventive Actions (CAPA).
• Assist with change control documentation and impact assessments related to manufacturing processes and procedures.
• Review and support updates to Standard Operating Procedures (SOPs) and other GMP documentation.
• Collaborate with Manufacturing, Quality Control, and other cross-functional teams to resolve quality issues and maintain compliance.
• Support internal audits and regulatory inspections, ensuring documentation and processes are inspection ready.
• Maintain accurate documentation of QA activities and quality events during shift operations.
• Provide GMP guidance and support to manufacturing staff to ensure proper documentation and process compliance.
• Act as client liaison to monitor client commitments, provide updates at product team meetings and manage progress of commitments to support Operations and Project Management Team.

Benefits

• In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan.
• All benefits are subject to eligibility requirements.
• Certain positions may also be eligible for additional compensation such as bonuses or commissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level