Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)
Merck
August 26, 2026
On-site
Rahway, NJ
Operations
Position Summary
- Establish and sustain safety, quality, and compliance culture across Building 880 FLEx Non-Sterile Operations; improve GMP compliance, safety performance, quality system governance, audit/inspection readiness, deviation/CAPA management, training compliance, risk management, and continuous improvement for reliable clinical supply execution.
Key Responsibilities
- Safety & Compliance Leadership: Champion safety culture; ensure adherence to site/corporate/regulatory safety requirements; partner across manufacturing, engineering, analytical testing, QA, and regulatory; support safety observations, incident investigations, risk assessments, and corrective actions; serve as GMP compliance SME; support clinical supply QMS implementation.
- Quality Systems & Inspection Readiness: Lead/support deviations, investigations, CAPAs, change controls, and risk assessments; drive audit/inspection readiness via monitoring and self-assessments; resolve compliance risks with Quality/EHS/Engineering/Operations; draft/review/advice on quality documents.
- Training & Procedural Governance: Oversee SOP lifecycle/procedural compliance; develop/update SOPs; monitor training/qualification; support standardized work and best practices.
- Continuous Improvement: Analyze safety/quality metrics; apply Lean/root-cause tools; promote right-first-time and sustainable compliance.
Required Qualifications
- BS in Engineering/Life Sciences/Chemistry or related; 4+ years GMP/pharma manufacturing; investigations/CAPAs/audits/quality systems experience; strong cGMP, compliance, safety knowledge; communication, problem-solving, cross-functional skills; manage projects/priorities; detail-oriented; flexible in dynamic environments; work across functions/sites.
Preferred Experience/Skills
- Drug product manufacture/testing; oral drug knowledge; R&D/clinical supply knowledge; Veeva and SAP.
Required Skills
- Clinical Trials Operations; Cross-Functional Collaboration; Detail-Oriented; Engineering Processes; Equipment Qualification; GMP Compliance; Operational Excellence; Performance Improvements; PHA; Process Optimization; Regulatory Compliance; Risk Analysis/Risk Assessments; RCA; Strategic Thinking; Technical Leadership; Technical Problem-Solving.
Compensation/Benefits & Apply
- Annual bonus/long-term incentive (if applicable); benefits include medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate/sick days.
- Apply: https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline shown on posting; job posting end date 08/18/2026.
- Establish and sustain safety, quality, and compliance culture across Building 880 FLEx Non-Sterile Operations; improve GMP compliance, safety performance, quality system governance, audit/inspection readiness, deviation/CAPA management, training compliance, risk management, and continuous improvement for reliable clinical supply execution.
Key Responsibilities
- Safety & Compliance Leadership: Champion safety culture; ensure adherence to site/corporate/regulatory safety requirements; partner across manufacturing, engineering, analytical testing, QA, and regulatory; support safety observations, incident investigations, risk assessments, and corrective actions; serve as GMP compliance SME; support clinical supply QMS implementation.
- Quality Systems & Inspection Readiness: Lead/support deviations, investigations, CAPAs, change controls, and risk assessments; drive audit/inspection readiness via monitoring and self-assessments; resolve compliance risks with Quality/EHS/Engineering/Operations; draft/review/advice on quality documents.
- Training & Procedural Governance: Oversee SOP lifecycle/procedural compliance; develop/update SOPs; monitor training/qualification; support standardized work and best practices.
- Continuous Improvement: Analyze safety/quality metrics; apply Lean/root-cause tools; promote right-first-time and sustainable compliance.
Required Qualifications
- BS in Engineering/Life Sciences/Chemistry or related; 4+ years GMP/pharma manufacturing; investigations/CAPAs/audits/quality systems experience; strong cGMP, compliance, safety knowledge; communication, problem-solving, cross-functional skills; manage projects/priorities; detail-oriented; flexible in dynamic environments; work across functions/sites.
Preferred Experience/Skills
- Drug product manufacture/testing; oral drug knowledge; R&D/clinical supply knowledge; Veeva and SAP.
Required Skills
- Clinical Trials Operations; Cross-Functional Collaboration; Detail-Oriented; Engineering Processes; Equipment Qualification; GMP Compliance; Operational Excellence; Performance Improvements; PHA; Process Optimization; Regulatory Compliance; Risk Analysis/Risk Assessments; RCA; Strategic Thinking; Technical Leadership; Technical Problem-Solving.
Compensation/Benefits & Apply
- Annual bonus/long-term incentive (if applicable); benefits include medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate/sick days.
- Apply: https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline shown on posting; job posting end date 08/18/2026.