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Click here or scroll down to respond to this candidateCandidate's Name
Quality Systems EngineerCollinsville, Street Address United StatesEMAIL AVAILABLE / 8473210160 https://LINKEDIN LINK AVAILABLESUMMARYExperienced quality control specialist with 20+ years in QA/QC and compliance for Fortune 500 pharmaceutical and medical device companies. Expertise in cross-functional team leadership, GMP project management, and validation and process improvement. Skilled in conducting CSV, cGLP, and cGMP compliance audits, data integrity reviews, product risk assessments, root cause analysis, IT deviations and CAPA management. In-depth knowledge of ICH guidelines, FDA 21CFR, and EU regulations, Proven success in developing and executing GMP Audit Gap Assessments and Supplier Audits Validation Master Plans and protocols. Identifying and resolving quality trend issues. Managed Supplier Quality agreements and NCRs for supplier qualifications. Proficient in GMP software like TrackWise and Master Control.SKILLSTeam BuildingProject ManagementSOP Creation & RevisionEquipment, Utility, Process ValidationGMP audits, Gap AssessmentsDeviation Investigations / CAPASFDA Audit RemediationDeviation root cause analysis.Change ControlProduct Risk AssessmentCustomer complaint investigations.Quality Analysis & Quality AssuranceCOMPLETED CONSULTING ASSIGNMENTS THROUGH TRINITY CONSULTING GROUP LLCConsultancy Premier FDA Solutions, LLC, Becton Dickenson, RemoteProject Scope: Tech Writer GMP Gap Assessment January 2023, June 30, 2023Perform GMP Gap assessment for the Quality Management System Index procedures for the Warwick and Vernon Hills sites.Completed GMP compliance gap of the Quality Management Index SOP for the Warwick and Vernon Hills manufacturing sites to align the site SOPs wi5j ISO 13485 specification and FDA 21 CFR 210, 211, & 212, Aligned the QMS SOPs with ISO 13485 standard. Verified SOP training was conducted for all SOPS. Data Integrity checks were performed for change controls and alignment with the ISO 13485 requirements.Consultancy Regulatory Compliance Group, Qualgen, Edmond OK HybridProject Scope: GMP Quality System Auditor, Lead Deviation Investigator GMP Auditor 07/2022 - 11/2022Led / Closed 10 FDA 483 deviations, (6 IT and 4 GMP deviations) cited in the consent decree audit for a 503-tablet manufacturing company.Revised SOP for deviation investigation SOP and report template and led deviation training class. Designed change controls to revise SOPs and productspecifications. GAP assessment was reviewed to ensure adequate steps were in place to address data integrity issues.Consultancy PS Biotech, Gilead La Verne, CA OnsiteProject Scope: GMP Quality System Audit of Engineering SOPs 04/2022 - 07/2022Reviewed 80+ SOPs for initiating, executing, and closing work orders for equipment calibrations for routine calibrations and out-of-tolerance conditions, new equipment qualifications, and utility maintenance. Maintained a constructive evaluation of quality-related systems through an SOP GMP gap assessment for the Gilead Engineering Department.Recommended revisions for engineering change and pest control SOPs, in alignment with 21 CFR Parts 2110, 2111 & 212.Consultancy JT Consulting Services, Abzena, Bristol, PA RemoteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 02/2022 - 03/2022Performed a 3-week GMP audit for medical device manufacturing operation. The audit verified compliance with ISO Spec 13485, USP 820, and EU regulations. Data integrity checks were performed to ensure raw material specification and supplier audits were completed. Final Report 7 GMP deviations cited / CAPAs were initiated.Consultancy Rayland & Associates, Catalent, RemoteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 05/2021 - 09/2021Conducted and led Quality Management Deviations/ CAPAs for biotechnology manufacturers. Led CAPA team meetings and prepared the necessarydocumentation. Closed 4 deviations that exceeded 90 days. Led CAPA meetings for supplier quality issues, manufacturing compliance issues, batch.records deviations, facility deviations, and customer complaints.Consultancy Automated Solutions, Baxter OnsiteProject Scope: Validation Deviation Tech Writer 10/2020 - 04/2021Executed validation protocols (IQ, OQ, and PQ) for installation and qualification of new equipment and software for a new form, fill, and sealmachine. The machine was designed for aseptically filling sterile pharmaceutical solutions. Initiated over 60 IT deviations cited during the execution ofthe OQ validation. All deviations were reviewed and closed by the Baxter QA department. Led team CAPA meetings for OQ deviations,Consultant Pharma Bio-Serve, GSK, OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 04/2020 - 08/2020Project lead for FDA warning letter. Closed 5 Batch Record Deviations. Led a team of 4 QA reviewers that reviewed and recommended corrections for over 1000+ closed batch records. Mentored and coached on floor manufacturing personnel for correction of batch records. Assisted with deviations / CAPAs for the release of products.Consultancy American Pharmaceutical Consulting, Apothecus, HybridProject Scope: GMP Quality System Auditor, Lead Deviation Investigator GMP Auditor 01/2020 - 04/2020Managed quality oversight for FDA Warning Letter issued to medical device manufacturing company Within 2 months, conducted a retrospective review of 400+ production batch records, including NCRs and deviations. Prepared a final report with findings and corrective actions for the client's FDA response.Consultancy OQSIE, Teva, OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 04/2020 - 08/2020 OnsiteDeviation Tech Writer for tablet manufacturers' site. Closed 2 IT and 8 GMP deviations cited in the FDA warning letter. Deviations were over one old which included batch records NCRs: equipment and process deviations. Prepared deviation / CAPA reports related to utility, facility, equipment, and tablet processing. Tracked deviations in TrackWise Quality Management Software.Consultancy Roland & Associates, Elite One Source, OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 08/2018 - 04/2019Led process improvement steps for manufacturing and packaging of OTC manufacturer tablets. Designed quality improvement plans to resolve regulatory compliance gaps, manufacturing and customer complaints, and deviations. Led, authored, and CAPs for tableting and packaging deviations. Reviewed batch records for data integrity issues and GDP issues.Consultancy Pharmaceutical Company Biotech, Allergan, OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 04/2018 - 06/2018Identified GMP errors for defects with aluminum tubes used for the manufacture of eye care products. Reviewed production batch records and NCRs in accordance with department policies. Developed new data integrity SOP, and a batch record review checklist.Consultancy Thomas Engineering, Pfizer, OnsiteProject Scope: Validation Deviation Tech Writer 01/2018 - 02/2018Executed utility and HVAC validation protocols for a project designed to shut down the aseptic manufacturing facility. The validation protocolsincluded clean steam, water for injection, OFCA, nitrogen, and HVAC systems. Executed protocols were reviewed to ensure.Consultancy Real Staffing, Zimmer Biomet, OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 04/2017 - 10/2017Conducted daily on-site audits for two manufacturing operations of orthopedics, knee, ankle, and sports injury components. Led a team of 4 engineers to review and revise 14,000 Non-Conformance Reports within a four-month period. Led and authored 10 deviation investigations issued against manufacturing, environmental monitoring, supplier quality, and validation master plan.Pharmaceutical Company, Greenfield, MS (Consultancy Bonny Ward, Plasmodium OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 01/2017 - 04/2017Led a team of 6 GMP consultants for review of qualification protocols for certification of Class 1000 Gowning, and Class 100 Aseptic Clean. Drafted validation protocol room, and upgrades to the HVAC and Building Management System. Guided a team of 6 consultants to initiate CAPAs, SOP changes, and document change control to address FDA Warning letter issued against facility, gowning, utility, lab practices, and manufacturing SOP.Consultancy PharmaBioServ, Ethicon, OnsiteProject Scope, Supplier QA Auditor 09/2016 - 12/2016Re-aligned medical device Supplier Quality Program by performing GMP assessment of the material supply chain for suture products. Initiated CAPAs and supplier change controls to realign specifications, material specifications, and suppliers. Developed a comprehensive supply chain database to align raw material specifications with approved suppliers.Consultancy Bonny Ward, Fresenius Kabi; OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator Sr. Consultant 05/2016 - 08/2016Consultancy Bonny Ward, Allergy Laboratory OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator Sr. Consultant 05/2016 - 08/2016Consultancy Real Staffing Zimmer Biomet OnsiteProject Scope: GMP Quality System Auditor, Lead Deviation Investigator 06/2015 - 11/2015FULL-TIME QUALITY ASSURANCE POSITIONSCAMBRIDGE MAJOR LABORATORIESAssociate Director of Manager Validation Department: 2013 - 2015Managed a Quality Team of 16 validation engineers. Completed 25 chemical reactor qualifications within 18 months as part of an FDA commitment. Trained validation engineers on how to conduct GMP and IT deviationsDirected validation activities of outside contract services for 20+ equipment and facility enhancement projects, delivering 100+ validation protocols within 1st year.Lead validation for installation of new WIF system, and clean room packaging facility.Resolved product complaints related to validation issues. Implemented a new SOP for Change Management within 30 days and integrated a Master Control software system to track change controls and validation master plans for the API manufacturing site.Spearheaded development of a new Quality Assurance/validation department for API manufacturing operation, overseeing a team of 16 and an operating budget of $900K. Designed and developed overall policies and procedures and set up a system to meet all cGMP requirements for approved API products' equipment, facility, utility, and process qualification. Appointed as QA Systems Auditor and Consultant in the 2nd half of 2015.Data integrity SOP for site engineering SOPs were issued to ensure objective evidence was documented for written or electronic records to establish specifications for process, direct work, and electronic records are maintained in compliance with the Quality Management SystemAbbott Laboratories - Third Party QA Manager: 2011- 2012Managed five contract manufacturing sites in charge of supplying 10+ aseptic and sterile fill and combo products.Led approval of deviations / CAPAs and managed equipment, customer complaints, process engineering change controls, and SOP revisions. Performed batch record reviews and determined production lot disposition.Reviewed and approved manufacturing and CAPAs for product recall for a Contract Manufacturer site. Utilized QMS software TrackWise for tracking customer complaints, deviations, change control, and validation protocols.Abbott - Senior Supply Quality Auditor: 2008 2011Maintained TrackWise for 3500+ suppliers. Conducted onsite audits for Third Party Contract Suppliers and Material suppliers for 5 Manufacturing and 5 Contract Manufacturing sites.Managed new and existing supplier qualifications: Wrote supplier Qualification Agreements, conducted onsite GMP audit, and managed NCRs and CAPAsPerformed 140+ onsite audits within a 4-year period. Conducted audits for the qualification of new suppliers, and re-certification for existing suppliers. Achieved the following accomplishments during tenure:Revised Corporate Supplier Audit Report TemplateRevised Abbott Corporate Supplier Quality Audit ProcedureTrained auditors from the US, EU, and South Asia Developed Supplier Quality AgreementsDeveloped Supplier Corrective Action PlansRevised Incoming Raw Material Quality Inspection PlansHospira Compliance Auditor 2008-2011 (Abbott N. Chicago was sold to the Hospira plant in 2008) Abbott Compliance Auditor 2004-2007 Abbott Sr Validation Engineer 1997 2004EDUCATION AND TRAININGBachelor of Science: Microbiology 12/1975University of Illinois Urbana Champaign - United StatesCERTIFICATIONSSix Sigma Green BeltISO 13485 audit |
