Sterility QA Specialist — GMP & Process Improvement

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

Benefits offered by this job

Medical insurance

Dental insurance

401(k)

Job summary

Merck's Micro Sterility Assurance Laboratory in West Point, PA seeks a Quality Specialist to provide quality oversight for sterility testing under GMP. You will review documentation, support deviations, change control, CAPA, and participate in root-cause analysis, data integrity, and audits.

This role offers opportunity to drive continuous improvement using MPS and collaborate across lab and quality teams. Flexible collaboration across departments is encouraged.

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

GMP Compliance

Quality Assurance

Laboratory Documentation

Deviation Management

CAPA

Data Integrity

Root Cause Analysis

Analytical Thinking

Communication

Teamwork

Technical Writing

Education

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

Job description

Merck's Micro Sterility Assurance Laboratory in West Point, PA seeks a Quality Specialist to provide quality oversight for sterility testing under GMP. You will review documentation, support deviations, change control, CAPA, and participate in root-cause analysis, data integrity, and audits.

This role offers opportunity to drive continuous improvement using MPS and collaborate across lab and quality teams. Flexible collaboration across departments is encouraged.