Elizabeth Hatch
Paragon
Summary
Quality Assurance Representative with extensive experience in manufacturing and quality control across multiple facilities. Proven ability to lead teams, manage production processes, and ensure compliance with cGMP, OSHA, and FDA regulations. Skilled in operating high-speed machinery and conducting thorough inspections to maintain product quality and safety. Demonstrated success in training new staff and optimizing workflows to enhance operational efficiency.
Overview
22
22
years of professional experience
Work History
Representative, QA
Novo Nordisk
Bloomington
12.2024 - Current
- In the Quality Assurance department, we are responsible for all aspects of quality assurance functions.
- The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements.
- Responsible for supporting the quality system for the calibration, preventive, and demand maintenance program and reporting associated metrics.
- Performs review of equipment calibration and preventative maintenance work orders.
- Maintains the equipment master data in the Computerized Maintenance Management System (CMMS).
- Collaborates with system owners to ensure compliance of the Equipment Management System is maintained in accordance with standard operating procedures.
- Manages and maintains equipment and controlled document files.
- Reviews and approves all facility and equipment records in support of GMP operations.
- Provides formal and informal training and guidance on use of the CMMS systems and provides technical assistance and training for personnel.
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
- Supports Production activities in process, performing AQL on finished product.
Quality Assurance Representative
Catalent Pharma Solutions
01.2022 - 12.2024
- In the Quality Assurance department, we are responsible for all aspects of quality assurance functions.
- The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements.
- Responsible for supporting the quality system for the calibration, preventive, and demand maintenance program and reporting associated metrics.
- Performs review of equipment calibration and preventative maintenance work orders.
- Maintains the equipment master data in the Computerized Maintenance Management System (CMMS).
- Collaborates with system owners to ensure compliance of the Equipment Management System is maintained in accordance with standard operating procedures.
- Manages and maintains equipment and controlled document files.
- Reviews and approves all facility and equipment records in support of GMP operations.
- Provides formal and informal training and guidance on use of the CMMS systems and provides technical assistance and training for personnel.
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
- Supports Production activities in process, performing AQL on finished product.
Room Lead
Catalent Pharma Solutions
Bloomington
10.2020 - 12.2021
- In this role, I run rooms and handle paperwork and any other issues that come up for the company.
- Any given day I have 10- 30 people that operate the machinery in the rooms.
Quality Assurance Technician II
Micronutrients
Indianapolis
03.2019 - 10.2020
- I work as a Quality Assurance Technician in a very fast paced manufacturing environment bagging tons of trace metals such as zinc, copper and manganese.
- I am in charge of preparing samples and analyzing the results in order to put out the best quality product.
- I have an excellent work ethic and I am very good at taking charge and figuring out the best route for any situation.
- I have only been here a little over a year and I have fully trained the last 5 people that have come to the quality team.
Quality Line Technician
Craft Mark Bakery
Indianapolis
09.2018 - 03.2019
- Collecting samples every 7 minutes, testing and recording all results in Infinity Proficient.
- Following all SQF and Haccp guidelines.
- I make sure everyone on the line GMP compliant and make sure the quality of the product is correct from start to finish.
- Currently I am trained in all labs and have outstanding reviews.
- I work independently and am very reliable.
- I use many different programs such as Microsoft 360, Proficient and SNAP QC.
- I am very easily trained and will learn anything to meet my job expectations.
Inbound Receiving
Chewy.com
Clayton
08.2018 - 09.2018
- Inbound receiving of large quantities of pet food and other products.
- I was pretty good, did correct counts and lots of heavy lifting.
- I was certified to drive move x and pallet jacks.
Fermentation Make Up Operator
Eli Lilly and Company
Indianapolis
08.2014 - 07.2018
- Execute ticket and procedure instructions, including collecting, recording, and using data to monitor and control the process.
- Maintain process/work areas in a clean and organized state.
- Promote Safety and Quality by learning, understanding, and strict adherence to Good Manufacturing Practices (GMP), cGMP guidelines, safety and environmental guidelines, and good documentation practices.
- Be the compliance model, exhibiting best practices and demonstrating knowledge of compliance requirements.
- Background in microbiology and cell culture activities.
Primary Manufacturing Associate
Cook Pharmica LLC
Bloomington
12.2012 - 08.2014
- Performing all prep duties, and learning the vial fill and syringe fill lines.
- Wrapping Pallets, Forklift Operation, Handling Raw materials, VHP, SIP, and Labeling.
Convertor/ Team Lead
Nice Pak Products
Mooresville
10.2010 - 03.2012
- Converting any paper or cloth towel into bricks of baby wipe, material handling and coding, handling all paperwork for the line, blade sharpening, cutting and slicing towel on the fly, purging machines, cleaning, producing quality product.
Material Handler/Forklift Operator
Dart Container
Horse Cave
10.2007 - 10.2010
- Driving forklifts, tow motors, and roll haulers, cleaning up plastic, grinding, removing product from the floor, wrapping, unloading semi-trucks, stacking flat cartons, hauling rolls for foam extrusion, hauling rolls for ops extrusion, helping operate forming lines, unclogging grinders, and whatever else they wanted me to do.
- I was also trained in extruders, working with ovens and pulling plastic, I was also starting my training as a machine operator on a line.
Trainer
White Castle
Martinsville
09.2003 - 09.2007
- Fast-paced order making, cleaning, leading the floor, training any new employees.
Education
High school -
Skills
- SAP
- Receivables
- Materials Handling
- Quality Inspection
- Forklift
- Lean
- Quality Assurance
- Receiving Clerk
- Microsoft Office
- Aseptic Technique
- Microsoft Excel
- HACCP
- Laboratory Experience
- Food safety
- Lean Manufacturing
- Research & Development
- Quality Systems
- Root Cause Analysis
- Shipping Receiving
- Maintenance
- Microbiology
- 5S
- Lean Six Sigma
- Recieving
- Microsoft Word
- Quality Management
- Mechanical knowledge
- Quality Control
- ISO 9001
- Makeup Application
- Process Improvement
- Quality Audits
- Heavy Lifting
- CGMP
- Calibration
- FDA Regulations
- Manufacturing
- Basic math
- Regulatory compliance
- Document control
- Process improvement
- Risk assessment
- Data analysis
- Technical training
- Root cause analysis
- Cross-functional collaboration
Personal Information
- Willing To Relocate: Anywhere
- Authorized To Work: US for any employer
Timeline
Representative, QA
Novo Nordisk
12.2024 - Current
Quality Assurance Representative
Catalent Pharma Solutions
01.2022 - 12.2024
Room Lead
Catalent Pharma Solutions
10.2020 - 12.2021
Quality Assurance Technician II
Micronutrients
03.2019 - 10.2020
Quality Line Technician
Craft Mark Bakery
09.2018 - 03.2019
Inbound Receiving
Chewy.com
08.2018 - 09.2018
Fermentation Make Up Operator
Eli Lilly and Company
08.2014 - 07.2018
Primary Manufacturing Associate
Cook Pharmica LLC
12.2012 - 08.2014
Convertor/ Team Lead
Nice Pak Products
10.2010 - 03.2012
Material Handler/Forklift Operator
Dart Container
10.2007 - 10.2010
Trainer
White Castle
09.2003 - 09.2007
High school -
Similar Profiles
Tanuja YadavTanuja Yadav
Senior SDTM Programmer at NOVO NORDISKSenior SDTM Programmer at NOVO NORDISK
Mohamad Nakli AldaoudiMohamad Nakli Aldaoudi
STUDENT ASSISTANT at Novo NordiskSTUDENT ASSISTANT at Novo Nordisk
Deeksha ShettyDeeksha Shetty
Department Coordinator -Project Office at Novo Nordisk Service Centre India Private LimitedDepartment Coordinator -Project Office at Novo Nordisk Service Centre India Private Limited
Lydie BarbereauLydie Barbereau
Operatrice-Coordinatrice at Novo Nordisk ProductionOperatrice-Coordinatrice at Novo Nordisk Production
Abby RolfAbby Rolf
Bartender at Hoosier queBartender at Hoosier que