Jamie Hargenrader
Broadway,NC
Summary
Pharmaceutical professional with 18 years of manufacturing and quality assurance experience. Skilled in providing QA oversight to manufacturing operations, as well as, providing QA approval for deviations, CAPAs, and change controls within various quality management systems.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist-Incident Management
Seqirus
Holly Springs, NC
07.2020 - 06.2024
- Perform QA review and approval of Level 1/Level 2 deviations in Trackwise ensuring correct root cause is assigned using the most appropriate RCA tool
- Certified Mentor for Level 1/Level 2 deviations
- Collaborate with stakeholders to identify effective, robust CAPAs
- Review and approve Change Controls, as well as, associated evaluation and implementation actions
- Perform QA review of product-impacting change controls prior to presenting to Change Review Board (CRB)
- Provide audit support for Health Authorities and Self Inspections in the backroom to fulfill pre-audit requests, as well as, request during inspections
- Perform Annual Product Quality Review (APQR) and create a sub-report documenting the analysis and identified trends.
Quality Assurance Specialist-Front Line Quality Assurance
Seqirus
11.2018 - 07.2020
- Responsible for real-time review of batch records and equipment logbooks concurrent with manufacturing operations on the production floor
- Perform QA self-inspections in defined areas to ensure areas are operating under a state of control, assess compliance with cGMP and SOPs, and to identify and correct internal issues
- Provide front line support to Manufacturing focusing on manufacturing each batch safely, on time, and in compliance with batch instructions and quality requirements
- Perform risk assessments to determine if a deviation, incident, or batch record is most appropriate when adverse events occur
- Support Upstream suite team as the SFQA lead including making quality decisions, reviewing/ approving SOP/BPR revisions, discussing effective CAPAs based on root cause, and focusing on process improvement, operational excellence, and process reliability within the group.
Manufacturing Associate
Novartis Pharmaceuticals
09.2010 - 11.2017
- Perform all tasks necessary for the production of vaccines in compliance with SOP’s and BPR’s in addition to: Real-time review of documentation used for GMP production activities
- Revisions of SOP’s and BPR’s for the 1.1 process for the 20L wave, as well as our new 3.0 process for 5K CIP, SIP, and Operations
- Trains and mentors new associates on the upstream process, good documentation practices and good manufacturing practices
- Owned process related deviations and completed investigations within the GMP timeline to ensure compliance
- Executed troubleshooting on production equipment and coordinated with support groups to resolve issues in a timely manner
- Communicated adverse events to triage team through email and participating in investigations to ensure prompt closure for batch release.
Bioprocess Technician
Pfizer
03.2006 - 09.2010
- Maintained integrity of class C and D manufacturing areas in compliance with SOP’s
- Cleaned, sterilized, and set-up production equipment used in the fermentation process
- Performed aseptic operations for cell expansion activities in Zone A biosafety cabinets
- Documented production activities in logbooks and BPR’s in accordance with GDP
- Achieved Six Sigma Red Belt certification and lead project to reduce man hours and promote time efficiency within the stocking process
- Gained experience in process automation systems such as MES, DeltaV, SAP, and LIMS.
Education
Bachelors of Science- Biological Sciences -
North Carolina State University
Raleigh, NC06.2019
Skills
- Certified trainer cGMP/GDP
- PI ProcessBook
- Trackwise
- Documentum (Electronic Document Management System)
- QDocs
- GLIMS
- DeltaV
- SAP
- QA mentor for minor/major deviations in Trackwise/Veeva
- Member of the audit readiness group and served as backroom support as runner, request keeper and SME prepper
- Change Control mentor in Trackwise
- Document Approver for standard operating procedures, batch production records, and protocols
- Detail Oriented
- Problem-solving skills
- Decision-Making
- Team Collaboration
- Customer Service
Certification
- Bioworks Certification (Central Carolina Community College 2006)
- Red Belt Six Sigma Certification (Pfizer 2007)
- Train the Trainer (Pfizer/Novartis/Seqirus 2007-2024)
- Veeva End User Classroom Trainer (Seqirus 2022)
- Wake Tech Technical Writing certification (Seqirus 2024)
Timeline
Quality Assurance Specialist-Incident Management
Seqirus
07.2020 - 06.2024
Quality Assurance Specialist-Front Line Quality Assurance
Seqirus
11.2018 - 07.2020
Manufacturing Associate
Novartis Pharmaceuticals
09.2010 - 11.2017
Bioprocess Technician
Pfizer
03.2006 - 09.2010
Bachelors of Science- Biological Sciences -
North Carolina State University