Pearl Pathways_P Bishop_2016
- 1. 2 9 E . M C C A R T Y S T R E E T , S U I T E 2 0 0 • I N D I A N A P O L I S , I N • 4 6 2 2 5 P H O N E : ( 3 1 7 ) 8 9 9 - 9 3 4 1 E M A I L : C O N T A C T @ P E A R L P A T H W A Y S . C O M W W W . P E A R L P A T H W A Y S . C O M Phillip Bishop SUMMARY Phillip Bishop has thirteen years of Quality Control (QC) laboratory experience and most recently held a leadership role in a GMP compliant QC Laboratory at a top tier contract manufacturer of sterile products. Phillip possesses in-depth knowledge of multiple test methods, typical pharmacopoeial procedures, and is an expert in endotoxin testing. He has experience in authoring regulatory documents including sections of DMFs. He has a thorough understanding of quality systems and processes as well as global health regulatory body requirements and has a track record of successful FDA and client audits. In his roles, Phillip has authored SOPs and implemented quality assurance processes. Phillip has worked effectively with diverse teams to ensure that the release and QC tests are performed for both in-process and finished manufactured products including stability testing. He has extensive experience with authoring deviation reports and the creation and resolution of CAPAs. Finally, Phillip has demonstrated success in leading a team of multiple analysts in a Six Sigma environment. Skills Extensive knowledge in reviewing and authoring quality control data and validation documentation Subject Matter Expert for Endotoxin Testing at Baxter Facility In-depth understanding of Pharmacopoeial Work Regulatory document authoring for DMFs Batch record review Use of analytical instruments for measuring specs (AA, GC, HPLC, FTIR, PH-meter, K.F, UV-VIS, Wet Chemistry, FlowCam, Osmolality analysis, Microscope particles, plate reader; Calibration of instruments) Vast knowledge in the field of LAL testing Writing and closing successful OOS/OOT/CAPA reports Experience with several laboratory software systems; Maintained and updated all records and lab books as well as training records Strong leadership/management skills Recent recipient of Kaizen and VIP awards for improving processes and providing cost savings
- 2. 2 9 E . M C C A R T Y S T R E E T , S U I T E 2 0 0 • I N D I A N A P O L I S , I N • 4 6 2 2 5 P H O N E : ( 3 1 7 ) 8 9 9 - 9 3 4 1 E M A I L : C O N T A C T @ P E A R L P A T H W A Y S . C O M W W W . P E A R L P A T H W A Y S . C O M Work Experience BaxterBioPharma Solutions 8/2003-7/2016 Quality Associate I (8/2003-8/2005) Executed release and Quality Control tests for both in-process and finished manufactured products, as well as Stability Testing; Wet Chemistry Techniques, Raw Materials Testing, USP/EP/JP testing techniques, Peer Reviews Quality Associate II (8/2005-12/2010); Group Leader Raw Materials (12/06-12/10) Endotoxin Testing, HPLC testing, ELISA development, Bioassay and immunoassay techniques; operated, troubleshot, calibrated, and repaired equipment and instrumentation; authored SOPs; Managed team of 8 associates – assigned work schedules, wrote LIRs, provided training on testing methods and operation of equipment Quality Associate III /Group Leader Finished Product and Stability (12/10-7/16) Endotoxin Facility Subject Matter Expert; Designed method development/validations for endotoxin testing; presented data, reports and results to current and potential clients; assisted clients with developing specifications for testing; assisted clients with problem solving issues surrounding method development and validation; point of contact for regulatory and client audits; worked with regulatory affairs updating Drug Master Files for clients to file with the FDA/EMEA; Managed team of 10 associates- assigned work, tracked turnaround times, performed client regulatory audits, managed multiple projects, met established timelines Education University of Indianapolis, May 2002 Indianapolis, IN, BS, Biology, Minor in Chemistry