Sterility QA Specialist - GMP & Continuous Improvement

MSD; Upper Gwynedd Township (Montgomery County); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

401(k) retirement

Paid holidays

Vacation

Sick days

Job summary

MSD is seeking a Quality Specialist to support the Micro Sterility Assurance Laboratory, ensuring GMP compliance, SOP adherence, and data integrity. You will review documentation, assist deviation investigations, and help drive CAPA and change control in a fast-paced 7-day operation.

This role emphasizes process improvement through MPS, collaboration with lab and quality teams, and participation in audits and risk assessments.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biochemistry, Chemistry, or related scientific discipline preferred.
• 1+ years of experience in a GMP-regulated environment, preferably in a microbiology or sterility assurance setting.
• Working knowledge of SOPs, deviations, investigations, and quality systems.
• Experience supporting laboratory testing and documentation review.
• Familiarity with continuous improvement tools and MPS principles preferred.
• Strong attention to detail, organizational skills, and analytical thinking.
• Effective communication and collaboration skills.
• Ability to work independently and within cross-functional teams.

Responsibilities

• Provide quality support to Micro Sterility Assurance laboratory operations and testing activities.
• Support Micro sterility assurance testing processes in accordance with GMP, SOPs, and applicable quality standards.
• Review laboratory documentation, records, and data for accuracy, completeness, and compliance.
• Assist in deviation investigation, documentation, and follow-up actions.
• Support quality system activities including change control, documentation review, and CAPA where applicable.
• Partner with laboratory staff and quality representatives to ensure compliance and timely resolution of quality issues.
• Contribute to process improvement initiatives using MPS to improve laboratory efficiency, standardization, and compliance.
• Participate in root cause analysis and problem-solving activities related to laboratory quality events.
• Ensure adherence to data integrity, documentation practices, and good laboratory practices.
• Support internal audits, inspection readiness, and other quality-related assessments as needed.
• Monitor trends, identify recurring issues, and recommend corrective and preventive actions.
• Assist with the implementation and maintenance of quality metrics and continuous improvement plans.
• Participate in daily tier meetings to review priorities, elevate issues, track action items, and support timely resolution of operational and quality concerns.

Skills

Adaptability

Analytical Instrumentation

CAPA Management

Continuous Improvement

Deviation Management

GMP Compliance

Good Laboratory Practices

Laboratory Documentation

Quality Metrics

Teamwork

Technical Writing

Trend Monitoring

Troubleshooting

Use of Laboratory Equipment

Education

Bachelor’s degree in Microbiology

Job description

MSD is seeking a Quality Specialist to support the Micro Sterility Assurance Laboratory, ensuring GMP compliance, SOP adherence, and data integrity. You will review documentation, assist deviation investigations, and help drive CAPA and change control in a fast-paced 7-day operation.

This role emphasizes process improvement through MPS, collaboration with lab and quality teams, and participation in audits and risk assessments.