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Bruce Bursey, Cqa Asq is listed as Consultant | Validation | Quality at i-Pharm GxP, based in Greensboro--Winston-Salem--High Point Area, United States. AeroLeads shows a work email signal at thermofisher.com and a matched LinkedIn profile for Bruce Bursey, Cqa Asq.
Bruce Bursey, Cqa Asq previously worked as Owner Representative - Eli Lilly at I-Pharm Gxp and Senior Validation Engineer at Grail. Bruce Bursey, Cqa Asq holds Ms Certificate, Engineering Management from Drexel University.
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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
Listed skills include Change Control, Quality System, 21 Cfr Part 11, Validation, and 16 others.
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Charlotte, North Carolina, Us
Act 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.
Menlo Park, Ca, Us
Provided 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.
Waltham, Ma, Us
Provided 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.
Waltham, Ma, Us
Provided 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.
Morrisville, North Carolina, Us
Provided 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.
New York, New York, Us
Auditing 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.
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Bruce Bursey, Cqa Asq works for i-Pharm GxP.
Bruce Bursey, Cqa Asq is listed as Consultant | Validation | Quality at i-Pharm GxP.
AeroLeads has found 1 work email signal at @thermofisher.com for Bruce Bursey, Cqa Asq at i-Pharm GxP.
Bruce Bursey, Cqa Asq is based in Greensboro--Winston-Salem--High Point Area, United States while working with i-Pharm GxP.
Bruce Bursey, Cqa Asq has worked for I-Pharm Gxp, Grail, Thermo Fisher Scientific, Sequence Inc., and Pfizer.
You can use AeroLeads to view verified contact signals for Bruce Bursey, Cqa Asq at i-Pharm GxP, including work email, phone, and LinkedIn data when available.
Bruce Bursey, Cqa Asq holds Ms Certificate, Engineering Management from Drexel University.
Bruce Bursey, Cqa Asq is listed with skills including Change Control, Quality System, 21 Cfr Part 11, Validation, Capa, Quality Assurance, Biotechnology, and Gmp.
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