Summary
Overview
Work History
Education
Skills
Timeline
Hi, I’m

Your Name

Summary

Driven Quality Assurance Specialist II with 17 years experience in a cGMP production environment. Sound decision making abilities and able to collaborate with groups or work independently.

Overview

16
years of professional experience

Work History

Thermo Fisher Scientific Inc.
Leesburg

Quality Assurance Specialist II
11.2020 - Current

Job overview

  • Identifies and establishes order of review for Finished Product batches according to Final Release of results by QC on production schedule and/or by the direction of QA Supervisor/QA manager.
  • Performs 1st and 2nd review of Finished Product batches prior to final release.
  • Maintains and ensures a 3 business day TAT for QA review on Finished products not associated with a PV, CO, LI, or SIR.
  • Assesses nonconformances (LIs, SIRs, CAPAs, SCARs) prior to completion of 1st/2nd review of Finished Products.
  • Reviews, assesses, and determines impact of change controls prior to 1st/2nd review completion.
  • Reviews and determines disposition of Returned Product Inspection forms for Finished products produced by Pegasus and Contract Finished products.
  • Coordinates with and ensures QA Specialist III has Return Inspection forms for products related to complaints.
  • Performs Reserve Sample inspections on Finished products.
  • Reviews, revises, and can author SOPs and other critical documentation in a (FDA/EMA/CLIA/PPTA) pharmaceutical/cGMP environment.
  • Tracks and updates information related to GDP documentation errors, test results, and release of Finished products.
  • Issues Finished Product batch paperwork and any additional paperwork to complete batch appropriately.
  • Pulls Finished Product samples for PV, Stability, QC additional testing and updates batch paperwork appropriately.
  • Coordinates with QA/QC/Operations management/Tech Services to assess and eliminate any QA issues with products or processes.
  • Educates and works with operation leads to establish a Culture of Quality with all personnel.
  • Performs Annual Product reviews for Finished products.

Biolife
Denton

Quality Management Representative
11.2019 - 11.2020

Job overview

  • Stays current with federal, state, local and company-specific rules, regulations, and practices.
  • Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety.
  • Ensures that SOP’s are current and that staff perform routine tasks according to SOP through direct observation.
  • Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements.
  • Tracks deviations and trending in operating procedures and policies through established mechanisms.
  • Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised.
  • Identifies potential SOP revisions as needed to support continuous improvement.
  • Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations.
  • Tracks responses to and evaluates effectiveness of corrective actions for errors.
  • Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
  • Coordinates management review meetings and participates in center staff meetings.
  • Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases.
  • Fosters teamwork. Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously and resolves conflicts proactively.
  • Provides timely feedback on performance and initiates disciplinary action when necessary.
  • Participates in the evaluation and review of center staff.
  • Ensures high levels of customer service and satisfaction. Meets and strives to exceed customer expectations.

National Oilwell Varco Inc
New Iberia

Quality Coordinator
11.2011 - 11.2019

Job overview

  • Reviews NAT Source and NAT Recovered maintenance for Testing Equipment, Rapid Print Machines, Decappers and PDM workstations.
  • Reviews computerized systems and temperature monitoring system for NAT Source and NAT Recovered.
  • Reviews External Nonconformances, NAT Sample Submission Forms, Change Controls, Printed Materials and Internal Nonconformances for NAT Source and NAT Recovered.
  • Reviews test results for DPX and MPX for NAT Source and NAT Recovered Testing.
  • Approves test results for DPX and MPX for NAT Source and NAT Recovered Testing.
  • Performs final review of test results prior to exporting of results to manufacturing plants and donor centers for NAT Source and NAT Recovered Testing.
  • Exports test results to manufacturing plants, source donor centers, and third party donor centers for NAT Source and NAT Recovered Testing.
  • Performs hold on test results to prevent the release of product if nonconformance is identified prior to or during release of test results.
  • Performs lot/reagent checks on incoming test kits and control kits for NAT Source and NAT Recovered Testing.
  • Performs review of Out of Service packets for testing instrumentation, refrigerators, freezers, decappers, Rapid Print Machines, and PDM workstations for NAT Source and NAT Recovered Testing.
  • Performs troubleshooting with local IT and external computerized systems consultant to address issues with the approval and release of results for NAT Source and NAT Recovered Testing.
  • Performs review and verification of Sample Receipt for NAT Source and NAT Recovered Testing.
  • Performs review of Manual Result Entries for NAT Source and NAT Recovered Testing.
  • Attends and participates in daily leadership meetings to discuss goals, nonconformances, and upcoming events.
  • Assists in the preparation and conducting of internal and external audits from regulatory agencies.
  • Assists in the development and implementation of Operational / Quality Excellence Initiatives. Yellow Belt LEAN certified, and have been a member of multiple teams for Kaizen projects. Familiar with DDFP. Performs 5S Audits.
  • Performs periodic review of SOPs and validation processes.
  • Certified trainer for review and approval of test results and maintenance review for both NAT Source and NAT Recovered Testing.
  • Participates on the Emergency Response Team for facility.
  • Ensures that CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented.
  • Documents, investigates, tracks/trends and follows up on all corrective actions and preventative measures for NAT Source and NAT Recovered nonconformances, as well as provide analysis of preventive actions on all incidents/errors as required.
  • Ensures that all staff is trained and maintains their competency to perform all assigned tasks.
  • Performs direct observations of performance of routine and quality control procedures.

Borgwarner Inc.
Kokomo Plant

Sr. Technician
07.2008 - 11.2011

Job overview

  • Performs OPS review for internal and external nonconformances for PCR Source and Recovered Plasma.
  • Completes daily tasks involved in the release of results for PCR Source and Recovered Plasma.
  • Writes, modifies, and reviews SOPs.
  • Performs manual entries of test results for PCR Source and Recovered Plasma.
  • Executes test cases for validation of pooling equipment, Rapid Print Machines, freezers, and refrigerators.
  • Reviews change control documents.
  • Performs review of batch records for PCR Source and Recovered Plasma.
  • Ensures samples are prebatched properly prior to pooling of plasma for PCR Source and Recovered Plasma.
  • Ensures technicians are properly trained and certified to perform their job functions.
  • Reviews computerized systems and temperature monitoring system for PCR Source and Recovered Plasma.
  • Reviews PCR Source and Recovered Plasma maintenance for Pooling Equipment, Rapid Print Machines, and Decappers.
  • Assists in the preparation and conducting of internal and external audits from regulatory agencies.
  • Assists in the development and implementation of Operational Excellence Initiatives. Yellow Belt LEAN certified, have been a member of multiple teams for Kaizen projects, and familiar with DDFP. Performs 5S audits.
  • Performs periodic review of SOPs and validation processes.
  • Conducts daily leadership meetings to discuss goals, nonconformances, and upcoming events.
  • Documents, investigates, tracks/trends and follows up on all corrective actions and preventative measures for PCR Source and Recovered Plasma nonconformances.

Education

University of Montevallo
Montevallo, AL

Bachelor of Science from Biology/Chemistry
05.2006

Skills

  • Problem-solving skills / Critical Thinking
  • Sound decision-making abilities
  • Adaptive team player
  • Time management
  • Detail-oriented
  • Superior organization skills
  • Proficient in MS Office
  • Strong written and verbal communication skills
  • Proficient in Electronic Document Management Systems

Timeline

Quality Assurance Specialist II

Thermo Fisher Scientific Inc.
11.2020 - Current

Quality Management Representative

Biolife
11.2019 - 11.2020

Quality Coordinator

National Oilwell Varco Inc
11.2011 - 11.2019

Sr. Technician

Borgwarner Inc.
07.2008 - 11.2011

University of Montevallo

Bachelor of Science from Biology/Chemistry