Donna Linzey
Gosport,Indiana
Summary
An accomplished and driven quality professional with extensive experience in quality assurance, document management, and customer service in the pharmaceutical industry. Established capabilities in production control and regulatory formatting to maintain compliance. Proven aptitude for consistently delivering scalable solutions that meet and exceed client and company expectations. Leverages excellent communication, interpersonal, and problem-solving skills to collaborate with team members and achieve operational excellence. Serves as a key contributor to the long-term success of the organization.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Assurance \ AQL Associate Representative
Novo Nordisk
Bloominington
07.2025 - Current
- Assisted in executing internal audits to verify compliance with regulatory standards.
- Maintained detailed logs of quality control measures and corrective actions taken.
- Assist manufacturing processes when problems arise
to meet on time delivery of our products. - Reviewing documentation and ensuring all policies,
standards operation procedures, and any other
work instruction are to date and in compliance. - Delegation tasks and goals each day amongst team
members such as room assignments, issues on the
production floor, and so on. - Conduct floor audits to ensure that company
policies are implemented and followed in all aspects
on the floor. - Directly work with upper management to come up
with solutions to continuously improve our processes,
reduce costs, limit waste, and increase overall
productivity. - Performance of AQL (Acceptable Quality Limits) on
all batches and ensured quality of product for
commercial use. - Quality Audits
- Batch Record View
- Inspecting Vials, Syringes, & Automated Machine
Inspection - Ensures manufactured product meets quality
standards - Use of measuring devices (Caliper, gauges, rulers)
- Defect Detection & Reporting
Quality Assurance Specialist I
CATALENT PHARMA SOLUTIONS
Bloomington, Indiana
01.2022 - 01.2024
- Created and implemented departmental policies, process improvements, and goals.
- Developed, reviewed, and approved change requests.
- Ensured all submitted quality documents possessed correct data and maintained regulatory formatting.
- Scanned, filed, and stored controlled facility documents and materials in site archive.
- Checked out controlled quality documents to facility personnel.
- Performed special projects as assigned along with regular scheduled duties.
Production Controller
CATALENT PHARMA SOLUTIONS
Bloomington, Indiana
01.2020 - 01.2022
- Utilized JDE and planning schedules to order materials and product from MMC.
- Kept secondary informed of inventory for work orders to be manufactured.
- Collaborated closely with all supporting areas to ensure proper completion of batches.
Senior Manufacturing Associate
CATALENT PHARMA SOLUTIONS
Bloomington, Indiana
01.2019 - 01.2020
- Packaged vials and syringes for shipment.
- Performed visual inspections of syringes and vials.
- Provided cross-training in shipping / warehouse to perform cycle counts and inventory.
- Adhered to CGMP guidelines and SOPs.
- Analyzed batch records for accuracy.
Medical Device Assembler
BOSTON SCIENTIFIC
Spencer, Indiana
01.2018 - 01.2019
- Built medical devices manually by soldering, wiring, and wrapping components.
- Operated automated machines to manufacture medical devices.
- Served as qualified trainer for packaging medical supplies for shipment and MES system.
- Performed review of batch records and inspected devices, ensuring quality.
Device Operator
KELLY SERVICES (ELI LILLY)
Indianapolis, Indiana
01.2015 - 01.2016
- Set up and operated machines to build and label medical devices.
- Inspected and monitored product quality.
- Followed proper documentation and verification guidelines.
- Performed review of batch records, SOPs, and sample documentation.
Education
High School Diploma -
Bloomfield High School
Bloomfield, INSkills
- JDE
- Microsoft Office Suite
- MES
- SharePoint
Certification
- APICS Certification
- Lean Six Sigma Yellow Belt Certification
- OSHA 10 Certification
- OSHA PIT Certification - Forklift, Pallet Jack, and Automated Pallet Jack
PROFESSIONAL DEVELOPMENT
- Safe Start Safety Training (40 hours)
- Kaizen Training
Timeline
Quality Assurance \ AQL Associate Representative
Novo Nordisk
07.2025 - Current
Quality Assurance Specialist I
CATALENT PHARMA SOLUTIONS
01.2022 - 01.2024
Production Controller
CATALENT PHARMA SOLUTIONS
01.2020 - 01.2022
Senior Manufacturing Associate
CATALENT PHARMA SOLUTIONS
01.2019 - 01.2020
Medical Device Assembler
BOSTON SCIENTIFIC
01.2018 - 01.2019
Device Operator
KELLY SERVICES (ELI LILLY)
01.2015 - 01.2016
High School Diploma -
Bloomfield High School