Senior QA Specialist, Quality Operations (Combination Products)
United Therapeutics Corporation
June 26, 2026
On-site
Raleigh-Durham-Chapel Hill Area
Operations
Responsibilities:
- Review GMP documentation (logbooks, pest control, waterlogs, calibration/maintenance, temperature monitoring, batch records, protocols) for accuracy, completeness, and UT compliance related to combination products.
- Perform quality assurance activities, including inspections of production equipment (cleanliness, gowning, area line clearances), in-process packaging checks, AQL inspections, and floor audits.
- Review and disposition manufacturing/packaging and combination product batch records and raw materials/components for clinical and commercial processes.
- Review quality control final product and stability data.
- Process rejected lots for destruction; process retention samples and items identified for storage.
- Create and revise SOPs and work instructions.
- Support cGMP via closure of quality events, CAPAs, and change controls (investigations, action items, effectiveness checks).
- Provide combination products data for annual quality reviews (AQR).
- Conduct Quality Operations training for the Quality Team related to cGMP activities (and review peer work assignments as applicable).
- Communicate KPIs/metrics to Quality Management; develop quality project initiatives (plans, timelines, deliverables).
- Participate in cross-functional site projects (software validation, test scripts, project planning).
- Independently interpret data to resolve complex quality issues; escalate unresolved items to Quality Management and area management.
- Support regulatory inspections and internal audits (documentation audit team, pre-audit facility inspections).
Minimum Requirements:
- Bachelor’s degree in a scientific or related technical discipline.
- 5+ years of relevant pharmaceutical industry experience in a cGMP-regulated environment.
- Experience reviewing batch/production/process control records.
- Strong data interpretation aligned to GMP requirements and procedures.
- Ability to work independently and in a multi-functional team; manage priorities, deadlines, and extended hours.
- Effective written and oral communication; handle confidential information.
- Proficient in Microsoft Excel, Word, and Adobe Acrobat.
Preferred Requirements:
- 2+ years of combination products experience.
- Ability to interpret multi-compendia documentation (USP/EP/JP).
- Knowledge of ERP/TrackWise Digital/SAP S4HANA/MasterControl.
Job Location:
- On-site at RTP, North Carolina 100% of the time.
- Review GMP documentation (logbooks, pest control, waterlogs, calibration/maintenance, temperature monitoring, batch records, protocols) for accuracy, completeness, and UT compliance related to combination products.
- Perform quality assurance activities, including inspections of production equipment (cleanliness, gowning, area line clearances), in-process packaging checks, AQL inspections, and floor audits.
- Review and disposition manufacturing/packaging and combination product batch records and raw materials/components for clinical and commercial processes.
- Review quality control final product and stability data.
- Process rejected lots for destruction; process retention samples and items identified for storage.
- Create and revise SOPs and work instructions.
- Support cGMP via closure of quality events, CAPAs, and change controls (investigations, action items, effectiveness checks).
- Provide combination products data for annual quality reviews (AQR).
- Conduct Quality Operations training for the Quality Team related to cGMP activities (and review peer work assignments as applicable).
- Communicate KPIs/metrics to Quality Management; develop quality project initiatives (plans, timelines, deliverables).
- Participate in cross-functional site projects (software validation, test scripts, project planning).
- Independently interpret data to resolve complex quality issues; escalate unresolved items to Quality Management and area management.
- Support regulatory inspections and internal audits (documentation audit team, pre-audit facility inspections).
Minimum Requirements:
- Bachelor’s degree in a scientific or related technical discipline.
- 5+ years of relevant pharmaceutical industry experience in a cGMP-regulated environment.
- Experience reviewing batch/production/process control records.
- Strong data interpretation aligned to GMP requirements and procedures.
- Ability to work independently and in a multi-functional team; manage priorities, deadlines, and extended hours.
- Effective written and oral communication; handle confidential information.
- Proficient in Microsoft Excel, Word, and Adobe Acrobat.
Preferred Requirements:
- 2+ years of combination products experience.
- Ability to interpret multi-compendia documentation (USP/EP/JP).
- Knowledge of ERP/TrackWise Digital/SAP S4HANA/MasterControl.
Job Location:
- On-site at RTP, North Carolina 100% of the time.