Senior QA Specialist - GMP Compliance & Audits

1000 Merck Sharp & Dohme LLC; Rahway (NJ); On-site; USD 106,000 - 167,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Specialist, Quality Assurance to review and approve GMP documentation for clinical supply manufacture, testing, release, and maintenance of our clinical supply programs.

The role collaborates with the Quality Program Lead to report results, resolve audit findings, and prepare for regulatory inspections while maintaining compliance with GMP, GDP, and EU requirements.

Qualifications

• BS in appropriate Science or Engineering discipline.
• 5 years of experience in the pharmaceutical or related industry.
• Understanding of GMP and Good Documentation Practices and EU regulations.
• Experience in QA, QC, analytical labs, manufacturing or related areas.

Responsibilities

• Review and approve GMP documentation for clinical supply manufacture and testing.
• Audit batch documentation, data, procedures, equipment and systems.
• Collaborate with Quality Program Lead to issue reports and resolve audit findings.
• Assist in inspections preparation and ensure readiness for regulatory reviews.

Skills

Attention to detail

Interpersonal skills

Verbal communication

Written communication

Quality assurance

Education

BS in science/engineering

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Specialist, Quality Assurance to review and approve GMP documentation for clinical supply manufacture, testing, release, and maintenance of our clinical supply programs.

The role collaborates with the Quality Program Lead to report results, resolve audit findings, and prepare for regulatory inspections while maintaining compliance with GMP, GDP, and EU requirements.