Senior Specialist Quality Assurance
Merck
June 25, 2026
Remote friendly (West Point, PA)
United States
Operations
Responsibilities May Include, But Are Not Limited To:
- Evaluate and disposition clinical supply materials to ensure conformance with applicable company policies/procedures and governing regulations.
- Coordinate and/or support preparation of procedures, processes, and quality improvements.
- Lead projects to improve process performance, including continuous process improvements, investigation CAPAs, and value capture projects to improve outcomes, reduce cost, and lower processing cycle times.
- Collaborate across cross-functional/business areas to ensure robust processing and continuous improvement.
- Assist in coordination of significant quality events, including fact finding, investigations, and clinical quarantine/recovery actions.
- Provide on-the-floor coaching/guidance to resolve operational/technical issues and deviations.
- Manage investigations, change requests, and project timelines to meet compliance and customer due dates; escalate potential misses and develop remediation plans.
Education:
- Minimum of a Bachelor’s degree with a technical emphasis in an appropriate scientific or engineering field.
Required Experience and Skills:
- 5+ years in pharmaceutical (or equivalent) GMP-related field in Technical, Regulatory, Quality, or Operations.
- Familiarity with clinical supply batch disposition (release), clinical supply operations, and/or regulatory filing activities.
- Experience authoring/reviewing/approving investigations, deviation management support, and CAPAs.
- Background in quality control/quality assurance/auditing/regulatory affairs.
- Detailed, flexible, and aware of production/quality control problems.
- In-depth knowledge of cGMPs and relevant regulatory requirements.
- Experience utilizing AI tools for routine tasks and project work.
- Leadership, strong oral/written communication, interpersonal and conflict resolution skills; teamwork with ownership/accountability.
- Ability to experiment, learn, adapt, pilot concepts, and demonstrate change management.
Preferred Skills:
- Independently manage multiple priorities and projects.
- Lead/support cross-functional teams, including senior management.
- Analytical/problem-solving skills; Lean Six Sigma and project management knowledge.
- ERP/MES, document management systems, SAP, PowerPoint, Excel, and Word competency.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Apply no later than the day before the posted application deadline.
- Evaluate and disposition clinical supply materials to ensure conformance with applicable company policies/procedures and governing regulations.
- Coordinate and/or support preparation of procedures, processes, and quality improvements.
- Lead projects to improve process performance, including continuous process improvements, investigation CAPAs, and value capture projects to improve outcomes, reduce cost, and lower processing cycle times.
- Collaborate across cross-functional/business areas to ensure robust processing and continuous improvement.
- Assist in coordination of significant quality events, including fact finding, investigations, and clinical quarantine/recovery actions.
- Provide on-the-floor coaching/guidance to resolve operational/technical issues and deviations.
- Manage investigations, change requests, and project timelines to meet compliance and customer due dates; escalate potential misses and develop remediation plans.
Education:
- Minimum of a Bachelor’s degree with a technical emphasis in an appropriate scientific or engineering field.
Required Experience and Skills:
- 5+ years in pharmaceutical (or equivalent) GMP-related field in Technical, Regulatory, Quality, or Operations.
- Familiarity with clinical supply batch disposition (release), clinical supply operations, and/or regulatory filing activities.
- Experience authoring/reviewing/approving investigations, deviation management support, and CAPAs.
- Background in quality control/quality assurance/auditing/regulatory affairs.
- Detailed, flexible, and aware of production/quality control problems.
- In-depth knowledge of cGMPs and relevant regulatory requirements.
- Experience utilizing AI tools for routine tasks and project work.
- Leadership, strong oral/written communication, interpersonal and conflict resolution skills; teamwork with ownership/accountability.
- Ability to experiment, learn, adapt, pilot concepts, and demonstrate change management.
Preferred Skills:
- Independently manage multiple priorities and projects.
- Lead/support cross-functional teams, including senior management.
- Analytical/problem-solving skills; Lean Six Sigma and project management knowledge.
- ERP/MES, document management systems, SAP, PowerPoint, Excel, and Word competency.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Apply no later than the day before the posted application deadline.