Summary
Overview
Work History
Education
Certification
Timeline
Generic

Rebekah H. Burkett

Mechanicsville,VA

Summary

Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.

Overview

23
23
years of professional experience
1
1
Certification

Work History

Senior Manager Quality Assurance

Abbott
03.2022 - Current
  • Implementation, maintenance and continuous improvement of the Quality Management System (QMS) ensuring business interactions between commercial, supply chain, warehouse, distribution and laboratory services are supported by an effective and compliant QMS.
  • Management Representative for Warehouse and Distribution site, lead site Management Reviews, manage and develop a team of quality professionals supporting site and cross-functional activities in a matrixed business organization.
  • Developing and delivering on Quality Improvement Plans (QIPs), identify compliance gaps and facilitate remediation activities utilizing risk-based prioritization, supplier management, TPM management and associated applicable agreements and relationships.
  • Quality lead for commercial launch activities including project management, process ownership, TPM label review and other associated launch deliverables.
  • Manage document control system, change control, quality control and training, gathering, analyzing and reporting on key quality metrics, including trending and analysis of non-conformance, CAPA, audit findings, etc.
  • Qualification and validation activities for equipment and software, warehouse qualification, including temperature monitoring systems and software implementation, audit readiness activities and lead and participate in site audits.
  • Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
  • Provided strong leadership to enhance team productivity and morale.
  • Implemented and developed operational standards, policies and procedures.
  • Streamlined and monitored quality programs to alleviate overdue compliance activities.
  • Assisted in organizing and overseeing assignments to drive operational excellence.
  • Managed six direct reports.

Site Quality Lead

Abbott
05.2020 - 03.2022
  • Quality support and project lead for various quality initiatives and improvements for eScreen, including overall US Toxicology Manufacturing, and Toxicology BU Commercial, Warehouse Entities and US Laboratories.
  • Advised and led process improvement team with deliberation, leadership and strategic planning.
  • Aligned, integrated and implemented all applicable policies.
  • Workstream lead for two QIP workstreams (Document Control and Change Control) for US Toxicology Manufacturing (includes three Toxicology sites; Ameditech, Immunalysis and eScreen) alignment efforts to policies, including leading cross-functional teams, performing gap assessments, procedure development/alignment, training and implementation.
  • Project lead to move all Toxicology US Laboratory audits and associated QIs and CAPAs from paper-based systems to electronic format in Agile PLM.
  • Abbott Certified CAPA Initiator, Certified CAPA Initiator/Evaluator, Investigator, Resolution Planner and Approver, mentor, train and support other personnel on Quality processes and procedures (Agile PLM, METRO, Change Control, Document Control, Good Documentation Practices).
  • Revise and develop applicable quality process documents for various Toxicology sites, METRO Learning Administrator, Agile PLM Super User.
  • Assist and participate in site audits (ARDx, AQR, FDA, etc.) for multiple Toxicology sites, develop QIPs and execute to assigned deliverables, TPM label approval and Commercial product launch.
  • Support and participate in Management Review, work and coordinate Change Orders, QIs, CAPAs and associated actions for many Toxicology sites and across sites.
  • Abbott Global Citizen Development Program Graduate in 2021 and Abbott Emerging Leader Program candidate for completion in 2022, manage one direct report (contractor).

Senior Quality Systems Specialist

Abbott
04.2013 - 05.2020
  • Site Administrator for ensur Electronic Document Management System, AgilePLM and METRO, troubleshoot user issues, train new users, perform user acceptance testing, manage daily document workflows, ensure timely review and approval of all quality documents.
  • QA Coordinator for all quality objects (CAPA, Quality Incidents, Audits, etc.), lead integration efforts of two legacy Quality Systems into one new Quality System.
  • Site Lead for Alere Informatics Agile PLM integration, validation, training and go-live, train other personnel on Quality processes and procedures.
  • Revise and develop applicable quality process documents and gap assessments, METRO Site Admin and METRO course development and training data management.
  • Global Quality Dashboard monthly metrics, develop, review and approve, Deputy Management Representative, manage and facilitate Management Review meetings.
  • Assisted, participated and facilitated site audits (internal, FDA, ISO, etc.), participated from initiation to completion in site ISO 13485 Certification effort, training matrix management and training coordinator.
  • Assist with software design file development, review, risk assessment and approval.

Quality Manager/Quality Lead

Pfizer
09.2010 - 06.2012
  • Lead and manage all quality issues at various third party contractors. Review, complete and/or approve related investigations, deviations, change controls, validations, protocols, etc., facilitate issues at the contractor to all areas of Contract Operations QA, ensure timely completion of commitments and CAPAs, experience with various different product categories (drug, cosmetic, dietary supplement) and Contractors.
  • Supported product transfers, technology transfers and product launches, development and negotiation of Quality Agreements and Technical Agreements, review of batch records, product release.
  • Experience in Contractor qualification process, active participant in Contractor audits, collaboration with Contractor on process improvement efforts.
  • Change Coordinator managing all regulatory changes for the site.

Supervisor QA Physical Inspection

Pfizer
03.2010 - 09.2010
  • Supervise daily activities and operations of the physical inspection group within Contract Operations QA.
  • Train personnel, provide guidance, resolve issues with instrumentation and inspection failures, work with contractors and distribution centers, revise and develop applicable SOPs/Job Aids, address personnel performance, ensure product quality and compliance, completed Lean Six Sigma Green Belt Certification project within the physical inspection area.
  • Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Devised and implemented processes and procedures to streamline operations.
  • Managed four direct reports.

QA Complaints Specialist

Pfizer
08.2007 - 03.2010
  • Process and complete quality investigations to address consumer complaints, evaluate consumer returned samples and retain samples, complete monthly annual product evaluation reports and trending reports.
  • Collaborate with contractors to complete complaint related investigations, revise and develop applicable SOPs/Job Aids, train other personnel in complaint processing.
  • Maintain complaint workflow organized and updated, ensure timely approval of all complaint reports and revisions, complete metric analysis and trending reports.
  • Serve on complaint related process flow and improvement teams.

QA/QC Chemist

Wyeth Consumer Healthcare
05.2002 - 08.2007
  • Perform HPLC, dissolution, TLC, UV-Vis and FT-IR testing on routine, in-process, release and stability Analgesic and Respiratory products.
  • Execute dissolution, FT-IR and/or HPLC testing needed to evaluate prototypes, process validation and development samples.
  • Method Development, Method Validation and Method Transfer for several dissolution test methods, laboratory notebook/logbook documentation per cGMP requirements.
  • Train personnel, instrumentation system owner, data acquisition and analysis using Totalchrom, Empower, Peak Pro and Excel, peer review and validation of laboratory data.
  • Operated specialized scientific equipment and performed complex procedures to execute high-level analytical testing tasks.
  • Advised chemists and laboratory technicians on existing and emerging quality control methods to enhance testing and research capabilities.
  • Generated technical reports and other documentation to record analytical test results and conclusions.
  • Prepared and standardized test equipment, test solutions and reagents to enable successful testing completion.

Education

Bachelor of Science - Chemistry, Physics

Longwood College
Farmville, VA
05-2001

Certification

  • Lean Six Sigma Green Belt Certification (LSSGB) - IASSC Lean Six Sigma Certification Board.

Timeline

Senior Manager Quality Assurance

Abbott
03.2022 - Current

Site Quality Lead

Abbott
05.2020 - 03.2022

Senior Quality Systems Specialist

Abbott
04.2013 - 05.2020

Quality Manager/Quality Lead

Pfizer
09.2010 - 06.2012

Supervisor QA Physical Inspection

Pfizer
03.2010 - 09.2010

QA Complaints Specialist

Pfizer
08.2007 - 03.2010

QA/QC Chemist

Wyeth Consumer Healthcare
05.2002 - 08.2007

Bachelor of Science - Chemistry, Physics

Longwood College

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Rebekah H. Burkett