Senior QA Specialist Biologics Quality & Compliance

MSD; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Specialist, Quality Assurance BDQR to provide quality oversight for analytical and process development activities in large molecule programs.

You will partner with stakeholders to ensure cGMP compliance, support deviations, CAPAs, and audit readiness while fostering a culture of quality and continuous improvement across GMP operations. The role requires 5+ years in pharma/biotech with a BS or 3+ with advanced degree, and strong GMP knowledge.

Qualifications

• Minimum of 5 years of experience in Pharmaceutical/Biotechnology industry role(s) with a BS, or 3+ years with an advanced degree.
• Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
• Strong compliance knowledge and understanding of health authority regulations and GMP interpretation in R&D environments.

Responsibilities

• Provide Quality oversight and execute GMP/GxP QA activities supporting manufacturing and testing operations.
• Review batch documentation and disposition; support deviations, investigations, CAPA and change controls.
• Partner cross-functionally to enable compliant start-up and execution of GMP activities; ensure audit readiness and quality metrics.

Skills

Audits Compliance

CAPA Management

Deviation Management

GMP Auditing

Manufacturing Processes

Operational Compliance

Operational Quality

Quality Assurance Processes

Quality Risk Management

Education

Bachelor’s degree in science, engineering, or related discipline

Tools

GMP systems

SAP

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Specialist, Quality Assurance BDQR to provide quality oversight for analytical and process development activities in large molecule programs.

You will partner with stakeholders to ensure cGMP compliance, support deviations, CAPAs, and audit readiness while fostering a culture of quality and continuous improvement across GMP operations. The role requires 5+ years in pharma/biotech with a BS or 3+ with advanced degree, and strong GMP knowledge.