Summary
Overview
Work History
Education
Skills
Websites
Publications
Timeline
Generic

Jennifer Hoffrage

Quality Assurance Manager
Memphis

Summary

Quality Assurance Manager with 15+ years management and pharmaceutical and biologics laboratory experience in the life sciences and medical device industries. Responsible for the development and implementation of Quality Systems, procedures and documentation to ensure global regulatory compliance. Effective team leader with ability to collaborate across the organization, multi-tasking while striving for accuracy and building strong relationships internally and externally. Strong communication skills, attention to detail and the ability to work in a fast-paced environment. Look to help develop strategies for continuous improvement where Quality leads by example and help develop training materials for better understanding. Willing to learn and grow in all aspects of Quality Management.

Overview

25
25
years of professional experience

Work History

Manager Quality Operations

Charles River Laboratories, Inc.
05.2023 - Current
  • Lead and mentor a diverse Quality team
  • Oversee batch release and lead Quality release of raw materials
  • Conducted GEMBA walks
  • Worked and collaborated cross-functionally to build better Quality and relationships between departments
  • Supported audits, mock recalls and smoke studies
  • Aided in Quality reviews and approvals of equipment validations as well as CSV validations
  • Reviewed EMPQ data and action level reports from environmental monitoring
  • Reviewed and approved electronic change orders for document updates, nonconformance investigations, lab data, out of specification (OOS) testing, aided in customer complaints, risk assessment, CAPA
  • Supported multiple clients with projects, onboarding and offboarding
  • Worked with Master Control, SmartSolve, Kneat, TrackWise Digital

Manager, Technical Quality Assurance

Meridian Life Science, Inc.
Memphis
11.2016 - 01.2023
  • Company Overview: (Formerly Viral Antigens, Inc.)
  • Lead and mentor a diverse Quality team
  • Author and review Policies, Standard Operating Procedures, Quality Manuals (QMS) working to keep up with regulatory standards
  • Managed, as a sub administrator, Master Control, electronic document management system, which included training within the system
  • Led OSHA/Safety Audits for multiple sites
  • Aided with Internal Auditing, Client led/Corporate audits and Regulatory (ISO 9001 and 13485) audits
  • Reviewed and approved electronic change orders for document updates, nonconformance investigations, lab data, out of specification (OOS) testing, aided in customer complaints, risk assessment, CAPA
  • Managed Calibration/Validation team, approving records and protocols and ensuring equipment was functional and met company needs and manufacturing specifications
  • Oversee batch release and document control and aided in the release of raw materials
  • Collaborated cross functionally with Manufacturing, Quality Control, Facility Operations and all departments to train and strengthen procedures, aid to implement corrective actions
  • Conducted training in Quality and Safety topics, including GDP, GMP, QMS topics
  • Aided in keeping up with key performance indicators and look for continuous improvement opportunities
  • Worked with Blue Mountain Regulatory Asset Manager, Microsoft Office and MAPIC-INFOR programs
  • (Formerly Viral Antigens, Inc.)

Master Control Site Manager, Clean Room Manager, Training Specialist

Meridian Life Science, Inc.
Memphis
02.2006 - 11.2016
  • Company Overview: (Formerly Viral Antigens, Inc.)
  • Trained personnel to work within the Clean Room area
  • Worked under 21 CFR 210 and 211 regulations within the Clean Room
  • Scheduled Clean Room activities including training, cleaning, production processes, environmental monitoring and any needed maintenance
  • Implemented use of cell factories and procedures for working with embryonated chicken eggs for influenza work
  • Provided procedures and training for TCID50, EID50 and HA Assays
  • Maintained aseptic technique in cell culture, buffer prep, final fill and finish
  • Authored and reviewed SOPs, Master Production Batch Records
  • (Formerly Viral Antigens, Inc.)

Therapeutic Production Specialist II

St. Jude Children’s Research Hospital
Memphis
07.2001 - 02.2006
  • Company Overview: (Children’s GMP, LLC)
  • Authored and reviewed Standard Operating Procedures, policies, Master Production Records
  • Worked under 21 CFR 210 and 211 regulations within the Clean Room
  • Maintained aseptic technique in cell culture, buffer prep, final fill and finish
  • Trained technicians and specialists
  • Aided in equipment calibrations and validations (IQ/OQ/PQ)
  • Acted as a beta tester to develop a new version of an inverted microscope
  • Performed method development for the manufacture of Phase I/II pharmaceuticals
  • (Children’s GMP, LLC)

Senior Technician

St. Jude Children’s Research Hospital
Memphis
07.2001 - 02.2006
  • Company Overview: (Flow Cytometery Lab, Immunology Department)
  • Operated MOFLO cell sorter, FACScan and FACSCalibur flow cytometers
  • Performed analysis of results
  • Trained technicians and post-doc fellows in the use of cytometers
  • Performed immunofluorescence staining of cells
  • (Flow Cytometery Lab, Immunology Department)

Lab Technician

Abbott Laboratories
Abbott Park
03.2000 - 06.2001
  • Performed microbroth dilution and disk diffusion testing
  • Provided the upkeep of bacterial cultures and media

Education

Bachelor of Science - Biology (emphasis Microbiology), minor in Chemistry

Southeast Missouri State University
Cape Girardeau, MO
01.1999

Bachelor of Arts - German

Southeast Missouri State University
Cape Girardeau, MO
01.1999

Skills

  • Quality assurance
  • Regulatory compliance
  • Change management
  • Document control
  • Training development
  • Cross-functional collaboration
  • Risk assessment
  • Team leadership
  • Safety procedures
  • Staff training and development
  • Key performance indicators
  • Coaching and mentoring
  • Performance evaluations
  • Goal setting
  • Verbal and written communication

Publications

  • Woloszynek, J., J. Champine, J. Hoffrage, J. Miller, M. Bluma, Ampicillin-resistant bacteria isolated from a meat packing plant sewage lagoon., Southern Association of Agricultural Scientists Bulletin: Biochemistry and Biotechnology, 13, 9-15, 01/01/00
  • Laurel S. Almer, Jennifer B. Hoffrage, Erika L. Keller, Robert K. Flamm, Virginia D. Shortridge, In Vitro and Bactericidal Activities of ABT-492, a Novel Fluoroquinolone, against Gram-Positive and Gram-Negative Organisms., Antimicrobial Agents and Chemotherapy, 48, 7, 2771-2777, 07/01/04

Timeline

Manager Quality Operations

Charles River Laboratories, Inc.
05.2023 - Current

Manager, Technical Quality Assurance

Meridian Life Science, Inc.
11.2016 - 01.2023

Master Control Site Manager, Clean Room Manager, Training Specialist

Meridian Life Science, Inc.
02.2006 - 11.2016

Therapeutic Production Specialist II

St. Jude Children’s Research Hospital
07.2001 - 02.2006

Senior Technician

St. Jude Children’s Research Hospital
07.2001 - 02.2006

Lab Technician

Abbott Laboratories
03.2000 - 06.2001

Bachelor of Science - Biology (emphasis Microbiology), minor in Chemistry

Southeast Missouri State University

Bachelor of Arts - German

Southeast Missouri State University
Jennifer HoffrageQuality Assurance Manager