QA Specialist II, Quality Operations; Combination Products
Job in
Chapel Hill, Orange County, North Carolina, 27517, USA
Listed on 2026-07-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-07-09
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA
Job Description & How to Apply Below
Who You Are
The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus.
Responsibilities- Review GMP documentation (logbooks, pest control, water logs, calibration/maintenance, temperature monitoring, batch records, protocols) for accuracy, completeness, and compliance.
- Perform quality assurance functions (inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections, floor audits).
- Review and disposition manufacturing, packaging, and Combination Products batch records and components.
- Review quality control final product data.
- Process rejected lots for destruction.
- Process retention samples for storage.
- Perform labeling activities (incoming inspection, issuance, cycle counts, SAP transactions, reconciliation of labeled/printed components).
- Create/revise SOPs and work instructions.
- Initiate/participate in closure of quality events and CAPAs assigned to Quality Operations.
- Provide Combination products data for annual quality reviews (AQR).
- Communicate with internal/external partners to resolve quality issues; elevate complex issues to Quality Management.
- Support quality project initiatives (plans, timelines, deliverables).
- Bachelor’s degree in a scientific or related technical discipline.
- 2+ years of relevant pharmaceutical industry experience in a cGMP regulated environment.
- Ability to work independently and in a multi-functional team; manage priorities, stressful situations, deadlines; work extended hours as needed.
- Effective written and oral communication at various organizational levels.
- Handle confidential company data.
- Ability to interpret data with company procedures and GMP requirements.
- Experience reviewing batch/production/process control records.
- Proficient in Microsoft Excel, Word, and Adobe Acrobat.
- 2+ years of experience in combination products.
- Knowledge of ERP, Track Wise Digital, SAP S4
HANA, and Master Control.
- On-site at RTP, North Carolina 100% of the time.
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