Phillip Hartley
Quality Assurance Production/ Logistics Supervisor
- Role
- Quality Assurance Supervisor at Globyz Biopharma Services
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Phillip Hartley
OUR MISSION@ Globyz Biopharma Services focuses on integrated customized solutions with the highest standard of quality and service level to make Globyz Biopharma Services the preferred sourcing and supply partner for our customers’ clinical trial material requirements and services.@Wuxi : Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks. Perform ing activities within production facilities to support manufacturing of Cell & Gene Therapy products and final product fills according to current Good Manufacturing practices (cGMPs).Clinical Trial Studies Quality Assurance Auditor / Inspector Assess and evaluate the adequacy, effectiveness, and efficiency of the QMS (Quality Management System) Ensure each product’s specification conform to GXP requirements.Manufacturing processes are clearly defined and controlled.Performed Quality Assurance inspections as per batch record requirements. Audit batch record documentation during audits.MAC Blister Packing Machine (Zanari-40E, PD8,CAP 8 & Elanco-Fill) Machine Operator, capsugel type 8, polisher capsule filler, polisher metalchek, key model CP 300WD, analytical balances, blender mixers, granulators, coaters, pharmaceutical metal detector, Bosch KKE 1500. Vacuum DesiccatorPerform challenge tests (i.e. leak test, fiber optic light, morpholine, visual, torque, label scanner, ink pressure detector, foil liner detector, check weigher, pinhole detector challenged, mocon oxygen level testing, OQ, OV & SUR performance) and AQL sampling conforming to ANSI/ASQ standardsSpecialties: JD Edwards B.C.S. Inventory release of clinical labels, reclassification of finish good samples, WIPS, and rejects. Monthly Inventory Report also acknowledge of using programs i.e. Track Wise for IR, PR, and CAPA. Sapien, Compliance Wire, Documentum
Experience
Quality Assurance Supervisor
Jan 2025 — Present · US
Quality Assurance /Production /Logistics Supervisor
Education
Pennsylvania Institute of Technology,
Duel A.A.S, Mechanical Engineering / Computer Engineering
1999 — 2002
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