Summary
Overview
Work History
Education
Skills
Timeline
Generic

Jeannette M. Bursee

Washington

Summary

I have experience managing quality management systems in regulated industries including pharmaceutical and medical device manufacturing, GMP and GLP, laboratory testing, and cleanroom monitoring as well as strong technical writing skills.

Overview

12
12
years of professional experience

Work History

Director of Quality

Rose Plastic Medical Packaging USA, L.L.L.P.
08.2022 - 02.2025
  • Audit and quality system management for ISO 9001 and ISO 13485 certification
  • Quality Management System maintenance (document control, document revision, training)
  • Calibration tracking of quality test equipment in SAP (used as a Calibration Management System), CAPA risk assessment in case of out of tolerance test equipment, trending of calibration results
  • Supervise and mentor Quality Associate
  • Monitoring of ISO 9 and ISO 8 cleanrooms (environment for plastic molding)
  • Handling and investigation of customer complaints
  • Support requests from customers for audit, quality surveys, product information, Quality Assurance Agreements
  • Production equipment qualification
  • Approval of investigational testing
  • CAPA process owner
  • Coordinate Quality Management Systems with Headquarters in Germany
  • Release of raw materials

Sr. QA Laboratory Specialist

Tolmar, Inc
04.2020 - 07.2022
  • Instrument calibration and requalification protocol and report review and approval, impact assessment in case of out of tolerance results or equipment failure
  • Reviews and approval of Laboratory Investigations (Phase I (lab) and Phase II (manufacturing) for OOS results) for sterile injectable products (filled syringes) and dermatology products
  • Attend planning meetings to support release of product and compliance to timelines
  • Regulatory assessment within three business days to determine if Field Actions are required in US or are communicated to domestic or international marketing partners
  • Review and approval of document changes and document change request
  • Change control impact assessment, review, and pre and post approval
  • Instrument requalification protocol and report review and approval
  • Approval of investigational testing
  • CAPA and effectiveness check identification, effectiveness check approval
  • Coordinate on development of training materials
  • Audit support (QA review, back room, preparation)
  • Provide mentorship to junior team members and to investigators

Regulatory Reporting Specialist (Contract through Modis Engineering)

Cook Medical, Cook Endoscopy
01.2020 - 04.2020
  • Complaint handling for endoscopy medical devices
  • Regulatory assessment and reporting for malfunctions and adverse events to domestic and foreign regulatory agencies

Deviation Investigator (Contract through New Age Systems)

Sandoz, a Novartis Division
11.2018 - 01.2020
  • Investigation of deviations for solid oral dose, cleaning processes, controlled environments and packaging operations
  • Deviation report preparation/technical writing
  • Identification of corrective and preventative actions (CAPAs) to address root cause of deviations
  • Determination of product impact
  • Complaints investigation – technical complaint handling/investigation of manufacturing processes

Quality Engineer/QA Associate III

Baxter
09.2017 - 10.2018
  • Investigation of non-conformances and deviations
  • CAPA ownership/change controls/document changes
  • Validation of equipment changes and new equipment for flexible container unit
  • Remediation for FDA warning letter

Quality Investigator (Expatriate position for 2 years) – Hospira Healthcare Pvt. Ltd.

Pfizer
09.2015 - 09.2017
  • Approver for laboratory and deviation investigations, provide oversight for identification of corrective and preventative actions, perform Notification to Management for critical investigations, main approver for chemistry laboratory and manufacturing science and technology departments (analytical section).
  • Areas of focus: QC laboratories, equipment and calibration, engineering maintenance, procedural gaps, validation issues, method transfer, out of specification (OOS) Phase I (lab) and Phase II (manufacturing), lab data systems, data integrity, and human error
  • CA/PA (Corrective and Preventative Actions) – improvement to laboratory systems for instrument calibration/qualification, procedure improvement to reduce error, resolution of vendor issues (API, raw material and packing material)
  • Mentor investigators and QA team members for technical writing in English, root cause analysis techniques, identification of realistic CA/PAs, and scope of product impact, measurement of CA/PA effectiveness

Quality Investigator/Quality Engineer

Hospira
09.2013 - 09.2015
  • Investigation of out of specification results (Phase I and II), equipment/instrument failures, and procedural deviations for the chemistry quality control lab
  • Provide writing support for other investigators
  • Perform product impact assessments within required timeline
  • Change control, SOP preparation, training
  • Gowning certification for controlled production areas
  • Purchasing of supplies and reagents for Chemistry laboratory according to approved supplier list
  • Lab walk through for audit readiness, compliance to procedures

Engineer II/Technical Support Engineer (Contract position)

Merck and Co.
01.2013 - 09.2013
  • Lead cross-functional quality investigations and identify CA/PA
  • Areas of focus: Automation Events, validation errors, environmental excursions, utility alarms, human error, batch record error, equipment failure, out of tolerance events for instrumentation
  • Developed working knowledge of aseptic processing and vaccine manufacturing process for bulk and fill/finish lyophilization to assess quality impact to product
  • Gowning certification for classified areas
  • SAP, LIMS systems, MES – Werum (manufacturing execution system/electronic batch records)

Education

B.S. - Chemical Engineering and Bioengineering

University of Pittsburgh
Pittsburgh, PA
05-2002

Skills

  • Microsoft Office
  • Minitab statistical software for DoE
  • SPSS statistical software
  • TrackWise
  • Blue Mountain CMMS
  • SAP as CMMS
  • Document Management Software
  • LIMs software
  • Werum MES
  • Veeva software

Timeline

Director of Quality

Rose Plastic Medical Packaging USA, L.L.L.P.
08.2022 - 02.2025

Sr. QA Laboratory Specialist

Tolmar, Inc
04.2020 - 07.2022

Regulatory Reporting Specialist (Contract through Modis Engineering)

Cook Medical, Cook Endoscopy
01.2020 - 04.2020

Deviation Investigator (Contract through New Age Systems)

Sandoz, a Novartis Division
11.2018 - 01.2020

Quality Engineer/QA Associate III

Baxter
09.2017 - 10.2018

Quality Investigator (Expatriate position for 2 years) – Hospira Healthcare Pvt. Ltd.

Pfizer
09.2015 - 09.2017

Quality Investigator/Quality Engineer

Hospira
09.2013 - 09.2015

Engineer II/Technical Support Engineer (Contract position)

Merck and Co.
01.2013 - 09.2013

B.S. - Chemical Engineering and Bioengineering

University of Pittsburgh