Quality Manager, Sr. Tech Analyst, Sr. Operations Analyst
Resume:
DAVID McBRIDE
Newbury Park, CA 91320
********@*****.***
SUMMARY
Quality professional with 20+ years experience within cGMP/GLP Quality Lab/Bulk Manufacturing and Engineering environments.
Proven success in developing and managing multiple groups/projects to achieve corporate objectives.
Resourceful problem solver with high standards and strong work ethic.
WORK HISTORY
Baxalta US Inc. / Baxter Bioscience Inc. Thousand Oaks, CA
Sr. Technical Analyst 2014 – Present
Core team member for design/development of Site Master Plan for the Thousand Oaks facility.
Participate in design, function and structure of manufacturing support groups.
Extensive knowledge of ISOTrain and BPLM databases in support of GMP compliance.
Revise and review of process methods, specifications and SOPs to ensure GMP compliance.
Non Conformance Primary Investigator. Design and implementation of Containment and Corrective Actions.
Work with QA and other supporting groups to facilitate event investigation and closure.
Quality Control Associate II 2013 – 2014
Operation / trouble shooting of HPLC and other laboratory instrumentation.
Conduct feasibility experiments to aid in the design of validation studies to support BAX855 (Adynovate) licensure.
Adynovate Core Team member representing Quality to ensure compliance support.
Perform Feasibility studies in support of validation activities for BAX855 sample types.
Execute validation protocols for BAX855 sample types.
Revise and review of Validation protocols, process methods, specifications, Forms, Worksheets, instrumentation logs and SOPs for compliance.
NCR Primary Investigator.
Work with QA and other supporting groups to facilitate event investigation and closure.
Proficient with Crystal Reports, Track Wise 7 & 8, SQL LIMS & NWA, Team Center, JDE, Wonder Ware, Delta V, and other software. Working process knowledge of BIM and OSI PI control systems.
Manufacturing Associate III 2008 – 2013
Operation / trouble shooting chromatography skids in the purification process of rAHF Factor VIII.
Operation / troubleshooting of various process systems to ensure production schedule adherence.
Ensure GMP/GDP compliance in the manufacturing areas.
Review and revise MBRs, MFRs and instrumentation logs for compliance.
Participate in cross-functional teams to improve process/GMP compliance.
Participate in investigations. Design and implementation of CAPAs to ensure compliance.
Revise and review of process methods, specifications and SOPs to ensure compliance.
Working knowledge of probes, autoclaves, process tanks, incubators, CIP/SIP and other systems used in the manufacturing process.
Yellow Belt trained.
Amgen Inc. Thousand Oaks, CA
Manager QC 2006 – 2007
Supervisor QC 2005 – 2006
Supervised and supported Chemistry HPLC and Instrumentation Groups.
Participated in and was a Point person for FDA audits.
Structured, planned, and monitored the day-to-day activities of 13 full time staff members.
Responsible for employee coaching, training, development and performance evaluations for direct reports.
Responsible for managing resources to ensure adequate product release cycle times are met in order to meet supply chain demands. Present weekly metric updates to SLT at sample/project status meeting.
Facilitated Frontline Manager Training (AMGEN).
Extensive knowledge of USP/NF, EP, ACS, FCC and JP compendia.
Executed and maintained systems to meet regulatory requirements (i.e. 21 CFR part 11) within the HPLC / Laboratory Instrumentation areas.
Support of Product Complaint Investigations per 21 CFR 211.204,198, 192, 194 with Nikon Measure Scope and Instron Tensile test exam instrumentation.
Frequent member of cross department teams to resolve analytical and compliance issues.
Facilitated cross-functional teams (QA/QC) to perform internal audits of various areas within Quality. (Document Control, Supplier Quality, Stability, Sample Control).
Write and respond to external/internal audit findings.
Devised and implemented CAPAs to address compliance issues.
Review/release of final product, validation data.
Quality Control Associate III (Group Lead) HPLC Chemistry group 2003 - 2005
Schedule/Coordinate sample testing and training of personnel on methods and instrumentation.
Technical data review and approval across several chemical analysis methodologies.
Executed the transfer of methods to contract labs and other Amgen sites.
Write and conduct validation of instruments and methods.
Conducted investigations in conjunction with Out Of Specification/Out Of Trend suspect results.
Extensive trouble shooting/problem solving knowledge of instrumentation and bench analysis.
Collaborate with various Product Quality Leaders and groups including Site Supply Chain, Manufacturing, Analytical Science, Process Development, Pharmaceutics, Technical Resources Group and Stability.
Quality Control Associate I/II (Group Lead) HPLC Chemistry group 1992-2003
Chemical analysis of small molecules and carbohydrates using HPLC and IC.
Reviewed and approved laboratory results, commercial and clinical.
Review of analytical method/SOP revisions.
Performed testing on in process and final product using various instrumentation.
Proficient with ICP, IR and UV-VIS Spectophotometry.
Osmometry, measure of osmotic pressure in buffers and final product.
Participated in the transfer of methods to QC for the Calcimimetics program (Sensipar).
Preformed HPLC/Dissolution, Disintegration analysis in support of Sensipar (Calcimimetics).
Preformed moisture analysis on various impurity standards.
Wrote and revised SOP’s for VanKel Media Mate and Oxygen meter.
Performed excipient analysis of Raw materials and in process/final dosage products using HPLC/IC
EDUCATION
M.S., Regulatory Affairs, Northeastern University.
B.A., Biology, California State University Channel Islands.
ADDITIONAL SKILLS / TECHNICAL EXPERIENCE
Proficient knowledge of USP/NF, ACS, FCC and EP compendia methods
Proficient in HPLC, IC, GC, ICP, USP Dissolution, USP Disintegration.
Proficient with Chem Station, Peak Net, Chromeleon and ATLAS data acquisition software
Sievers TOC Analyzers.
FT-IR, NIR and UV-VIS Spectrophotometry.
Verification and calibration of laboratory equipment
Karl Fisher Moisture analyzer (Coulometric and Volumetric).
CLASSES / CERTIFICATES RECEIVED
AAPS/USP Workshop, Dissolution: Current and Emerging Practices-
Methodology, Technology and Regulatory Issues.
Troubleshooting and maintenance of HPLC/GC/IC systems (Hewlett Packard/Dionex).
FDA Regulated Water Systems (Center for Continuous Education).
The Practice of Modern HPLC (LCResources Inc.).
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