Elizabeth Hatch
Paragon,IN
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
20
20
years of professional experience
Work History
Quality Assurance Representative
Catalent Pharma Solutions
01.2022 - Current
- Responsible for all aspects of the 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
- 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
10.2020 - 01.2022
- Run large scale productions rooms
- Have 10-30 people that operate the machinery in the rooms.
- Organize paperwork and Ensure clear direction is given to operators
- Write IDFs and identify non compliances/ deviations
- Ensure quality of product before it goes out the door
- Review and complete all master batch record pages and forms
- Identify opportunities for continuous improvement
- working with minimal supervision
Quality Assurance Technician II
Micronutrients
03.2019 - 10.2020
- Quality Assurance Technician in a very fast-paced manufacturing environment bagging tons of trace metals such as zinc, copper, and manganese
- In charge of preparing samples and analyzing the results in order to put out the best quality product
- Have an excellent work ethic and I am very good at taking charge and figuring out the best route for any situation
- Fully trained the last 5 people that have come to the quality team.
Quality Line Technician
Craft Mark Bakery
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
08.2018 - 09.2018
- Inbound receiving of large quantities of pet food and other products
- Correct counts and lots of heavy lifting
- Certified to drive move x and pallet jacks.
Fermentation Make Up Operator
Eli Lilly and Company
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
03.2012 - 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
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
Dart Container
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
09.2003 - 09.2007
- Fast-paced order making, cleaning, leading the floor, training any new employees.
Education
High School Diploma -
Martinsville High School
Martinsville, IN06.2005
Skills
- Shipping/ Receiving
- Operations Maintenance
- Forklift
- FDA Regulations
- CGMP
- Manufacturing
- Microbiology
- Quality Control
- Quality Assurance
- Heavy Lifting
- Laboratory Experience
- Research & Development
- Aseptic Technique
- SAP
- Six Sigma Green Belt
- Materials Handling
- Calibration
- Mechanical knowledge
- Food safety
- Microsoft Excel
- Basic math
- Microsoft Word
- Microsoft Excel
- Process Improvement
- Quality Inspection
- HARPC
- ISO 9001
- Quality Audits
- Root Cause Analysis
- Technical Writing
Timeline
Quality Assurance Representative
Catalent Pharma Solutions
01.2022 - Current
Room Lead
Catalent Pharma Solutions
10.2020 - 01.2022
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
03.2012 - 08.2014
Convertor/ Team Lead
Nice Pak Products
10.2010 - 03.2012
Material Handler
Dart Container
10.2007 - 10.2010
Trainer
White Castle
09.2003 - 09.2007
High School Diploma -
Martinsville High School
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