Sr. Specialist, Quality Assurance (Nights)
Core
Develop and implement compliant quality systems to assure products and services are reliable, safe, and effective in a regulated environment.
Role type
Senior Quality Assurance Specialist (cGMP)
Builds
Quality systems, documentation, and product release activities for pharmaceutical/medical device manufacturing.
Domain
Healthcare / Pharmaceutical Manufacturing / Quality Assurance
Required skills
Root cause analysis, CAPA management, CGMP compliance, documentation review, chromatogram analysis (HPLC, Gas Chromatography), gap assessments, aseptic review, cross-functional collaboration
Preferred skills
Microbiology/Chemistry/Biology/Physics background, cGMP experience, ISO experience, pharmaceutical or medical device industry experience
Technologies
SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, Microsoft PowerPoint, E-Z Scan radiometric TLC scanner
Responsibilities
Review and disposition manufacturing batch records, validation documentation, and change controls; Perform product release activities per CGMP requirements; Monitor and close CAPA investigations; Establish and report metrics related to products and processes; Perform aseptic reviews with operations; Conduct gap assessments against quality requirements
Seniority
Senior, hands-on IC
