Debbie Lemons, ASQ CQA

Experience

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  Abbott

  Mar 1998 - Feb 2002

  Production Supervisor, Small Volume Parenterals- Terminal Sterilization/ Filling and Packaging

  Led, coached and mentored up to 60 non-exempt employees and served as the first line of supervision for the Filling and Packaging operations including 5 terminal sterilization lines consisting of ampoules, glass and plastic vials and 10 packaging lines. Audited batch records for accuracy and compliance. Served as an Subject Matter Expert (SME) during regulatory inspections and client audits. Authored departmental Standard Operating Procedures (SOPs) and ensured adherence to the procedures. Performed other duties related to employee hiring, performance feedback, reviews, and disciplinary actions. Show less

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  Hospira

  Feb 2002 - Aug 2015

  Successfully led a team of 6 to eliminate the Annual Product Quality Review (APQR) 3 year backlog. Annual reviews were completed for total of 429 List numbers, a total of 172 product groupings while operating in a fast paced environment. Streamlined the process and made process improvements which led to compliance and elimination of compliance risk. Developed tracking tools, metrics, weekly communications and glidepaths to enhance the delivery of timely executed reports. Coordinated the schedules and preparations of the annual product reviews in accordance with 21CFR 211.180 (e). Hiring manager/personnel development/ coaching and mentoring / performance management of workforce Show less Development and performance management of 7 labs with up to 35-40 direct reports including coaching, career development, and performance evaluation. Successfully managed the final product laboratories which included: sterility, bacterial endotoxin testing, particulate matter technology, sub-visual particulate, data analysis, media prep and potency. Managed the laboratory workforce to ensure timely completion of testing and release of products.Developed and maintained the tracking tool for Biological Quality Exception Reports (ERs) to show status of ERs, conducted daily meetings and drove timely closure of ERs.Hiring manager for both non-exempts and exempts for the Biological Quality workforce (total of 88 employees). Authored and tracked Validation Change Requests (VCRs) through completion. Served as a scribe for multiple Regulatory agency inspections and One2One Customer audits. Show less

  • Annual Product Quality Review (APQR) Manager

    Nov 2012 - Aug 2015

  • Sr. Supervisor Biological Quality Laboratories- Final Product

    Feb 2002 - Nov 2012
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  Pfizer

  Aug 2015 - now

  Successful Project team lead for Pfizer Quality Standard (PQS) project consisting of the integration of 129 Pfizer quality standards and alignment with Legacy Hospira Quality Systems. Inspection Readiness program lead- coordinate, schedule and lead inspection readiness meetings with senior leadership to ensure the site is in a state of inspection readiness.Coordinate and schedule inspection/audit activities for multiple Regulatory Agencies, Pfizer CentreOne customers, and Corporate functions. Recognition received for my outstanding leadership and contribution while supporting FDA, Corporate and Third Party Inspections/Assessments. Serve as a liaison in multiple Regulatory Agencies, Pfizer CentreOne customers, and Corporate function inspections and audits. Manage the Quality Management Review program, Compendial Compliance, and site metrics.Perform internal audits, author and issue audit reports in accordance to company standards and timelines. Ensure clear communication to relevant team members and/or functional area management. Review responses to audit findings for appropriateness and completeness. Follow up with team members as needed to obtain responses and ensure timely closure in the CAPA management system. Support Pfizer CentreOne customer audits by coordinating the audits, serve as liaison/audit room administrator, receive the audit report, communicate to the relevant team members for the appropriate responses, and deliver the final response to the audit team lead. Enter and track the audit activities in the Global Quality Tracking System (gQTS). Proven track record to work in a fast paced environment with multiple projects in process and drive impressive results to meet deadlines. Show less

  • QA Manager, Auditing

    Oct 2021 - now

  • Sr. Regulatory Compliance External Lead Auditor

    Aug 2015 - Oct 2021
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  Pfizer Inc

  Aug 2018 - Oct 2021

  Interim Sr. Regulatory Compliance Manager