Sterility Assurance QA Specialist

Merck & Co.; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck & Co., Inc. in West Point, Pennsylvania is seeking a Quality Specialist to oversee sterility assurance testing within the Micro Sterility Assurance Laboratory.

You will ensure GMP compliance, review documentation for accuracy, and drive continuous improvement with quality systems and CAPA activities. The role involves collaboration with lab and quality teams, participation in root cause analyses, trending of quality data, and support for audits and inspections.

Qualifications

• 1+ years of experience in a GMP-regulated environment, preferably in microbiology or sterility assurance.
• 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.

Responsibilities

• Provide quality support to Micro Sterility Assurance laboratory operations and testing activities.
• Support Micro sterility assurance processes 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

GMP Compliance

Quality Assurance

Deviation Management

CAPA Management

Laboratory Documentation

Technical Writing

Education

Bachelor's degree in Microbiology/ Biology/ Biochemistry/ Chemistry/ related scientific discipline

Job description

Merck & Co., Inc. in West Point, Pennsylvania is seeking a Quality Specialist to oversee sterility assurance testing within the Micro Sterility Assurance Laboratory.

You will ensure GMP compliance, review documentation for accuracy, and drive continuous improvement with quality systems and CAPA activities. The role involves collaboration with lab and quality teams, participation in root cause analyses, trending of quality data, and support for audits and inspections.