Bruce Bursey, Cqa Asq work email
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Bruce Bursey, Cqa Asq personal email
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Highly accomplished Validation professional with experiences qualifying pharmaceutical, biotechnology, medical devices, and laboratory technology. Significant experience interpreting and applying SOPs and Quality System regulations as they relate to validation practices. Proficient in the development and application of system development life cycle policies and procedures. Broad experience with diverse systems from lab instruments, equipment, and clean utilities to enterprise-wide systems. Works well under pressure and with users of varying skill levels.Experiences:•Customer Inquires•Global Teams•Computer System Life Cycle (including 21CFR Part 11)•Equipment IOPQ•Group Leading•Risk Assessments•Change Control and CAPA•Quality Compliance Validation Knowledge:•CSV•Laboratory Instruments•Hot/Cold Storage (including Walk-Ins)•Autoclaves•Clean Utilities•Isolators•HVAC Certification•Room Qualification
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Owner Representative - Eli LillyI-Pharm Gxp Jun 2024 - PresentCharlotte, North Carolina, UsAct as owner representative for $2Billion dollar building investment providing quality oversight and monitoring third party progress for 4 buildings. This includes reviewing and approving AHU automation specifications, IV/OVs, discrepancies, and final reports. -
Senior Validation EngineerGrail Oct 2023 - Apr 2024Menlo Park, Ca, UsProvided CSV expertise for stand-alone and automated medical device workcell instrument start up project. Author Configuration Specifications, conduct Software Assessments, provide validation solutions, and work with cybersecurity team for the NovaSeq X+ sequencer. -
Regulatory SpecialistThermo Fisher Scientific Aug 2021 - Apr 2023Waltham, Ma, UsProvided global validation and compliance expertise for laboratory equipment and system installation and operational qualification. Work with Product Managers, R&D, Engineering, and Marketing on new product launches and equipment updates. Design, implement and provide training (in-person and virtually) to field personnel. -
Validation Engineer Ii- IiiThermo Fisher Scientific Aug 2015 - Jul 2021Waltham, Ma, UsProvided senior validation expertise supporting computer laboratory systems (CFR Part 11) and manufacturing equipment systems meeting all federal and site regulations and policies.Responsible for data integrity projects and managed the CSV Periodic Review and CTU RQ programs. Led AD/QC discussion that was the forum for laboratory change management.
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Senior ConsultantSequence Inc. Sep 2013 - Jun 2015Morrisville, North Carolina, UsProvided laboratory instrument and equipment validation expertise to key Biotechnology clients. Team member for a global PC and instrument upgradeWrote URS, Risk Analysis, Validation Plans, IOPQ, Trace Matrices and Summary ReportsWorked with third party vendors installing refrigerators in sales representative homes for storage of drug product. Qualified refrigerators prior to shipping to sales representative homes. -
Validation Specialist IvPfizer 2002 - Jan 2013New York, New York, UsAuditing Function:Developed and implemented internal audit plan including quarterly clean utilities.Led cross-functional teams facilitating risk assessments increasing operational excellence and reducing non-value activities.Led teams ensuring department compliance with site and company policiesValidation Function:Wrote and performed equipment qualification activities supporting manufacturing and the QC laboratories (Autoclaves, Sterility Isolators, Refrigeration, Clean Utilities...)Commissioned and qualified new QC facility housing Chemistry, Microbiology and Technical Support Laboratories meeting Consent Decree. Included supervising contractors.Automated Site’s validation document review and approval process, increased document tracking, and reduced document comment resolution cycle time.
Bruce Bursey, Cqa Asq Skills
Bruce Bursey, Cqa Asq Education Details
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Drexel UniversityEngineering Management -
Indiana State UniversityLife Sciences
Frequently Asked Questions about Bruce Bursey, Cqa Asq
What company does Bruce Bursey, Cqa Asq work for?
Bruce Bursey, Cqa Asq works for I-Pharm Gxp
What is Bruce Bursey, Cqa Asq's role at the current company?
Bruce Bursey, Cqa Asq's current role is Consultant | Validation | Quality.
What is Bruce Bursey, Cqa Asq's email address?
Bruce Bursey, Cqa Asq's email address is br****@****her.com
What schools did Bruce Bursey, Cqa Asq attend?
Bruce Bursey, Cqa Asq attended Drexel University, Indiana State University.
What skills is Bruce Bursey, Cqa Asq known for?
Bruce Bursey, Cqa Asq has skills like Change Control, Quality System, 21 Cfr Part 11, Validation, Capa, Quality Assurance, Biotechnology, Gmp, Fda, Gxp, Quality Control, V&v.
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