Supervisor, Quality Control - RMOMAL
United Therapeutics Corporation
August 25, 2026
On-site
Raleigh-Durham-Chapel Hill Area
Operations
Supervisor of Quality Control (QC)
Responsibilities:
- Supervise QC operations for testing of raw materials, in-process samples, drug substances, and drug products in accordance with cGMP and UT standards; may support limited R&D and contract testing.
- Coordinate and prioritize day-to-day laboratory activities (routine/ad-hoc testing, method transfers, equipment qualification, calibration/maintenance).
- Perform hands-on QC testing using wet chemistry and cell-based methods.
- Coordinate with external contract laboratories (sample shipment, method transfers, data review, compliance).
- Provide oversight of OOT/OOS/deviation investigations and CAPA; escalate complex events to QC Management.
- Review/approve analytical chemistry data packages for conformance to specifications and cGMP.
- Serve as primary point of contact for routine testing status; escalate non-routine issues.
- Draft/review protocols, summary reports, and SOPs; support testing as needed.
- Support IQ/OQ/PQ of new/transferred laboratory equipment; coordinate vendor work.
- Implement regulatory/compendial changes relevant to QC Analytical Chemistry.
- Provide training and on-the-job oversight for Analytical Chemists/Analysts.
- Troubleshoot instrument and LIMS issues.
Minimum Requirements:
- Bachelor’s in chemistry or other scientific discipline.
- 5+ years GMP pharmaceutical lab experience.
- cGMP/QC lab knowledge; wet chemistry and cell-based assay experience; LIMS and cGMP documentation familiarity.
- Strong written/verbal communication; detail-oriented and able to work independently.
- Experience managing contract labs and reviewing external data packages.
- Prior lead experience.
Preferred Qualifications:
- Master’s degree.
- 1+ year people management.
- Method transfers, IQ/OQ/PQ, delegation-matrix data review/approval.
- OOT/OOS/deviation investigations and CAPA execution knowledge.
Benefits:
- Medical/dental/vision/prescription coverage; wellness resources; 401k/ESPP; paid time off and paid parental leave; disability benefits.
Responsibilities:
- Supervise QC operations for testing of raw materials, in-process samples, drug substances, and drug products in accordance with cGMP and UT standards; may support limited R&D and contract testing.
- Coordinate and prioritize day-to-day laboratory activities (routine/ad-hoc testing, method transfers, equipment qualification, calibration/maintenance).
- Perform hands-on QC testing using wet chemistry and cell-based methods.
- Coordinate with external contract laboratories (sample shipment, method transfers, data review, compliance).
- Provide oversight of OOT/OOS/deviation investigations and CAPA; escalate complex events to QC Management.
- Review/approve analytical chemistry data packages for conformance to specifications and cGMP.
- Serve as primary point of contact for routine testing status; escalate non-routine issues.
- Draft/review protocols, summary reports, and SOPs; support testing as needed.
- Support IQ/OQ/PQ of new/transferred laboratory equipment; coordinate vendor work.
- Implement regulatory/compendial changes relevant to QC Analytical Chemistry.
- Provide training and on-the-job oversight for Analytical Chemists/Analysts.
- Troubleshoot instrument and LIMS issues.
Minimum Requirements:
- Bachelor’s in chemistry or other scientific discipline.
- 5+ years GMP pharmaceutical lab experience.
- cGMP/QC lab knowledge; wet chemistry and cell-based assay experience; LIMS and cGMP documentation familiarity.
- Strong written/verbal communication; detail-oriented and able to work independently.
- Experience managing contract labs and reviewing external data packages.
- Prior lead experience.
Preferred Qualifications:
- Master’s degree.
- 1+ year people management.
- Method transfers, IQ/OQ/PQ, delegation-matrix data review/approval.
- OOT/OOS/deviation investigations and CAPA execution knowledge.
Benefits:
- Medical/dental/vision/prescription coverage; wellness resources; 401k/ESPP; paid time off and paid parental leave; disability benefits.