Associate Specialist, Quality Systems & Compliance
Merck
June 26, 2026
On-site
Durham, NC
Corporate Functions
Quality Assurance Associate Specialist – supports laboratory and manufacturing quality operations for vaccine product manufacturing facilities.
Primary Activities Could Include
- Perform review of batch records, laboratory records, and associated documentation.
- Provide quality guidance and assist with deviation identification and initiation.
- Perform data review and run reconciliation activities as required (e.g., UV and FIT testing).
- Learn new processes and procedures.
- Perform shift work as required.
- Support housekeeping and self-inspections.
- Perform quality retain sample management activities, if applicable.
Education Minimum Requirements
- High School Diploma or equivalent.
Required Experience and Skills
- Minimum two (2) years’ experience in Manufacturing, Maintenance, Military environments, or related industry experience.
- Must be able to work a 12-hour night shift (6:00 pm to 6:00 am) on a 2-2-3 schedule.
Preferred Experience and Skills
- Good interpersonal skills including flexibility and collaboration.
- Demonstrated analytical aptitude, critical thinking, and problem solving.
- Good verbal and written communication skills.
Required Skills
Analytical problem solving; aseptic filling; cGMP compliance; deviation management; quality assurance; quality auditing; quality management systems (QMS); root cause analysis (RCA); sterile procedures; process improvement projects; complaint management.
Primary Activities Could Include
- Perform review of batch records, laboratory records, and associated documentation.
- Provide quality guidance and assist with deviation identification and initiation.
- Perform data review and run reconciliation activities as required (e.g., UV and FIT testing).
- Learn new processes and procedures.
- Perform shift work as required.
- Support housekeeping and self-inspections.
- Perform quality retain sample management activities, if applicable.
Education Minimum Requirements
- High School Diploma or equivalent.
Required Experience and Skills
- Minimum two (2) years’ experience in Manufacturing, Maintenance, Military environments, or related industry experience.
- Must be able to work a 12-hour night shift (6:00 pm to 6:00 am) on a 2-2-3 schedule.
Preferred Experience and Skills
- Good interpersonal skills including flexibility and collaboration.
- Demonstrated analytical aptitude, critical thinking, and problem solving.
- Good verbal and written communication skills.
Required Skills
Analytical problem solving; aseptic filling; cGMP compliance; deviation management; quality assurance; quality auditing; quality management systems (QMS); root cause analysis (RCA); sterile procedures; process improvement projects; complaint management.