Quality Operations Specialist - GMP & Micro Sterility

MSD; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) and health benefits

Medical, dental, vision coverage

Job summary

MSD in West Point, PA is seeking a Quality Specialist to help ensure sterility assurance testing complies with GMP, SOPs, and company quality standards. You will review data, participate in investigations, and support CAPA and change control to drive continuous improvement.

The role emphasizes data integrity and collaboration with laboratory and quality teams, with a focus on improving efficiency and overall compliance in a 7-day operational environment. A 1+ year GMP background is preferred.

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.

Responsibilities

• Support Micro Sterility Assurance testing activities in accordance with GMP, SOPs, and quality standards.
• Review laboratory documentation, records, and data for accuracy and compliance.
• Assist in deviation investigations, documentation, and follow-up actions.
• Support quality system activities including change control, documentation review, and CAPA.

Skills

Quality systems

GMP experience

Documentation review

Deviation investigations

CAPA

Data integrity

Analytical thinking

Communication

Cross-functional teamwork

Education

Bachelor’s degree in Microbiology, Biology, Biochemistry, Chemistry, or related scientific discipline

Tools

MPS

CAPA

Change control

Job description

MSD in West Point, PA is seeking a Quality Specialist to help ensure sterility assurance testing complies with GMP, SOPs, and company quality standards. You will review data, participate in investigations, and support CAPA and change control to drive continuous improvement.

The role emphasizes data integrity and collaboration with laboratory and quality teams, with a focus on improving efficiency and overall compliance in a 7-day operational environment. A 1+ year GMP background is preferred.