Manager, Quality Control
Merck
2 hours ago
On-site
Omaha, NE
Operations
Quality Control (QC) Manager
Position Responsibilities:
- Advocate “Safety First, Quality Always” via periodic Gemba walks.
- Manage QC and testing processes; coordinate lab activities; ensure tests meet internal/external regulatory requirements and lead times.
- Review testing results/data; identify abnormal events for escalation; prepare QC metrics reports and discuss results.
- Hire, train, mentor/coach technicians; set/achieve objectives; conduct performance evaluations; handle interpersonal conflicts.
- Lead investigations of QC testing issues; support method transfer from R&D/other departments to QC.
- Write/revise test methods, SOPs, production outlines, test records/forms; ensure QC documents meet regulatory requirements; write/review technical reports for submission to USDA or other health authorities.
- Support annual budget preparation and documentation for capital equipment/supplies.
- Participate in special projects as assigned.
Other Duties May Include:
- Strategic planning for departmental priorities.
- Support regulatory inspections/audits and validation activities.
Education:
- BS in Microbiology, Biology, Biochemistry, Chemistry, or related.
Required Qualifications/Skills:
- QC lab testing systems/procedures; USDA testing procedures, supplemental assay methods, and 9 CFR regulations; 3–5 years supervisory experience in biologics; GMP documentation experience; strong organization/planning; communication; technical writing; strong computer skills.
Preferred Qualifications/Skills:
- Knowledge of USDA/GMP/FDA/EMEA vaccine manufacture; assay validation & report writing; lean/six sigma.
Benefits (if applicable): Medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate/sick days; bonus/long-term incentive if applicable.
Apply: https://jobs.merck.com/us/en (deadline listed on posting). Requisition ID: R390560.
Position Responsibilities:
- Advocate “Safety First, Quality Always” via periodic Gemba walks.
- Manage QC and testing processes; coordinate lab activities; ensure tests meet internal/external regulatory requirements and lead times.
- Review testing results/data; identify abnormal events for escalation; prepare QC metrics reports and discuss results.
- Hire, train, mentor/coach technicians; set/achieve objectives; conduct performance evaluations; handle interpersonal conflicts.
- Lead investigations of QC testing issues; support method transfer from R&D/other departments to QC.
- Write/revise test methods, SOPs, production outlines, test records/forms; ensure QC documents meet regulatory requirements; write/review technical reports for submission to USDA or other health authorities.
- Support annual budget preparation and documentation for capital equipment/supplies.
- Participate in special projects as assigned.
Other Duties May Include:
- Strategic planning for departmental priorities.
- Support regulatory inspections/audits and validation activities.
Education:
- BS in Microbiology, Biology, Biochemistry, Chemistry, or related.
Required Qualifications/Skills:
- QC lab testing systems/procedures; USDA testing procedures, supplemental assay methods, and 9 CFR regulations; 3–5 years supervisory experience in biologics; GMP documentation experience; strong organization/planning; communication; technical writing; strong computer skills.
Preferred Qualifications/Skills:
- Knowledge of USDA/GMP/FDA/EMEA vaccine manufacture; assay validation & report writing; lean/six sigma.
Benefits (if applicable): Medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate/sick days; bonus/long-term incentive if applicable.
Apply: https://jobs.merck.com/us/en (deadline listed on posting). Requisition ID: R390560.