This document provides information on Phillip Bishop's extensive 13 years of experience in quality control and laboratory leadership roles. It outlines his skills and expertise in areas such as endotoxin testing, analytical testing techniques, authoring regulatory documents and standard operating procedures, batch record review, and laboratory management. His most recent role was as Group Leader and Subject Matter Expert in endotoxin testing at Baxter BioPharma Solutions, where he oversaw quality testing, assisted clients, and managed a team of analysts.

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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

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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