Senior QA Specialist, Quality Operations (Combination Products)

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; elevate 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. #J-18808-Ljbffr Scorpion Therapeutics