Quality Control Specialist
Merck
August 21, 2026
On-site
Wilson, NC
Operations
Position Responsibilities:
- Responsible for stability laboratory data review, plant site release, review of site APR, data trending, and support of Quality Notifications and CAPAs.
- Demonstrate mastery of data management/documentation programs (GLIMS, MEDS, IPI, SAP, etc.).
- Maintain positive site relations; support internal and third-party manufacturing/packaging sites.
- Assure compliance with FDA and GMP regulations.
- Influence cross-functional teams (Global Support and external organizations) and act as a recognized resource.
Key Functions:
- Work independently and as a team member; support objectives aligned with site goals.
- Initiate/lead problem solving to prevent repeat issues, reduce lab downtime, and improve reliability.
- Escalate safety/quality events per standard work.
- Timely approval of qualification, change control, procedures, and other documents.
- Perform stability and plant site release and study approvals.
- Support GLIMS updates; review builds and IPI specification verification; review technical memos and testing protocols.
- Attend stability data review/reporting meetings; serve as liaison among teams, leadership, and external entities.
- Interpret quality policies/guidelines for daily application; participate/direct tier meetings.
- Provide statistical summary analysis for Annual Product Reviews (APR).
Education Requirements:
- BS in Chemistry, Biology, or Engineering; ≥ 2 years in a pharmaceutical laboratory setting.
Required Experience/Skills:
- Prior pharmaceutical laboratory experience.
- Knowledge/experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.).
Required Skills:
- Adaptability; analytical instrumentation; analytical method development; dissolution testing; continuous improvement; GMP compliance; Karl Fischer titrations; laboratory documentation/safety; microbiological analysis/testing; teamwork; technical writing; troubleshooting; use of lab equipment.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if internal).
- Responsible for stability laboratory data review, plant site release, review of site APR, data trending, and support of Quality Notifications and CAPAs.
- Demonstrate mastery of data management/documentation programs (GLIMS, MEDS, IPI, SAP, etc.).
- Maintain positive site relations; support internal and third-party manufacturing/packaging sites.
- Assure compliance with FDA and GMP regulations.
- Influence cross-functional teams (Global Support and external organizations) and act as a recognized resource.
Key Functions:
- Work independently and as a team member; support objectives aligned with site goals.
- Initiate/lead problem solving to prevent repeat issues, reduce lab downtime, and improve reliability.
- Escalate safety/quality events per standard work.
- Timely approval of qualification, change control, procedures, and other documents.
- Perform stability and plant site release and study approvals.
- Support GLIMS updates; review builds and IPI specification verification; review technical memos and testing protocols.
- Attend stability data review/reporting meetings; serve as liaison among teams, leadership, and external entities.
- Interpret quality policies/guidelines for daily application; participate/direct tier meetings.
- Provide statistical summary analysis for Annual Product Reviews (APR).
Education Requirements:
- BS in Chemistry, Biology, or Engineering; ≥ 2 years in a pharmaceutical laboratory setting.
Required Experience/Skills:
- Prior pharmaceutical laboratory experience.
- Knowledge/experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.).
Required Skills:
- Adaptability; analytical instrumentation; analytical method development; dissolution testing; continuous improvement; GMP compliance; Karl Fischer titrations; laboratory documentation/safety; microbiological analysis/testing; teamwork; technical writing; troubleshooting; use of lab equipment.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if internal).