QA Specialist - II
Unicon Pharma Inc
Schedule: Monday-Friday; occasional nights/weekends during manufacturing campaigns. Core Responsibilities: QA oversight and approval of Deviations, OOS, Change Controls, CAPA, and EV records . Ensure investigations, escalations, and resolutions meet GMP procedures and timelines . Support resolution of manufacturing, product, environmental, facility, equipment, and material issues. Identify process efficiencies while maintaining compliance. Work collaboratively in a fast-paced manufacturing environment. Must-Haves: Bachelor’s + 2+ years relevant biological sciences experience, or equivalent education/experience. GMP knowledge , preferably U.S. and EU standards. Experience with QA/QC in a biologics/manufacturing environment is highly valuable. Strong experience with Deviations, OOS, CAPA, and Change Controls . Strong communication, collaboration, and problem-solving skills. Proficiency with MS Word, Excel, PowerPoint . Flexibility for occasional night/weekend manufacturing support . #J-18808-Ljbffr Unicon Pharma Inc
Vacancy posted 2 days ago
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