Senior QA Specialist, Biologics — GMP & Compliance

Merck & Co.; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck & Co. in Rahway, NJ is seeking a Senior Specialist, Quality Assurance BDQR to provide Quality oversight and technical support for analytical and process development activities supporting large molecule programs, while ensuring cGMP compliance and company requirements.

You will partner with cross-functional teams, review batch documentation, manage deviations, CAPAs, change controls, and audit support, and contribute to continuous improvement and training within a fast-paced, global

Qualifications

• Minimum of 5 years of experience in Pharmaceutical / Biotechnology industry role(s) with a BS, or 3+ years with an advanced degree.
• Experience in Biologics Quality, Biologics Manufacturing, and/or related functions at pilot and/or commercial scale.
• Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
• Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R&D environment.
• Demonstrated ability to manage projects and priorities to meet deliverables and timelines.
• Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

Responsibilities

• Provide Quality oversight and execute GMP/GxP quality assurance activities supporting manufacturing and testing operations, including material and batch documentation review and batch disposition.
• Provide Quality oversight of an evolving biologics clinical space by identifying potential compliance risks, escalating issues as appropriate, and helping ensure compliant execution in fast-paced operational areas.
• Support operational readiness by partnering cross-functionally to enable compliant start-up and execution of GMP activities.
• Apply a quality-by-design mindset by supporting appropriate use of quality systems, procedures, and documentation controls through planning, execution, and routine operations.
• Build and maintain effective partnerships with key stakeholders to provide Quality guidance, support timely decision-making, and contribute to oversight of quality events, including deviations, change controls, CAPA, and audit support.
• Contribute to a culture of compliance and continuous improvement by supporting training expectations, audit readiness, and quality performance monitoring/metrics.
• Remain informed of current GMP requirements and industry trends in the large molecule, analytical, and manufacturing areas to applicable worldwide regulations and industry standards.

Skills

Audits Compliance

CAPA Management

Deviation Management

GMP Auditing

Manufacturing Processes

Operational Compliance

Operational Quality

Quality Assurance Processes

Quality Assurance Systems

Quality Risk Management

Education

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

Tools

SAP

Job description

Merck & Co. in Rahway, NJ is seeking a Senior Specialist, Quality Assurance BDQR to provide Quality oversight and technical support for analytical and process development activities supporting large molecule programs, while ensuring cGMP compliance and company requirements.

You will partner with cross-functional teams, review batch documentation, manage deviations, CAPAs, change controls, and audit support, and contribute to continuous improvement and training within a fast-paced, global