Eric Winters
Flemington,NJ
Summary
Skilled Quality specialist focused on performing appropriate and useful analysis of products and component materials in order to drive quality improvements in manufacturing environments.
Overview
11
11
years of professional experience
Work History
Quality Control Inspector II
AbbVie
02.2019 - 10.2024
- Inspect incoming human and porcine tissue materials and connected documentation for 100% compliance with specifications.
- Work with other departments to resolve discrepancies.
- Work in an FDA regulated environment.
- A six-month Internal Internship in the Validation Engineering department.
- Document NCRs (Non-Compliance Reports) into Quality Management System.
- Update and write SOP procedure documents and drive updates through a change control system.
- Inspected quality of products, taking note of functionality, appearance and other specifications.
- Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.
- Maintained compliance with industry regulations through meticulous record-keeping and documentation of inspection results.
- Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification then moved them through the Change Control Process.
- Edited and proofread technical documents for accuracy and consistency.
Production Operator II
Allergan
04.2016 - 02.2019
- Manufactures the human tissue product AlloDerm as part of a production team
- Formally trained to execute laboratory procedures under aseptic procedures inside of a cleanroom
- Major contributor to Good Observations program
- Documented production information via daily system logs and discussed issues with management.
- Used equipment properly to avoid workplace hazards or injuries.
- Developed strong communication channels with team members, fostering a collaborative work environment that resulted in improved processes.
- Boosted team productivity by training new hires and cross-training existing employees on multiple tasks.
- Handled raw materials efficiently, minimizing waste during production process.
- Set up and adjusted equipment and properly configured machines for daily operation.
- Met production targets and tight deadlines by collaborating closely with team members.
Production Operator I
Lifecell as a temp through Kaztronics
09.2015 - 04.2016
- Manufactures the human tissue product AlloDerm as part of a production team
- Formally trained for executing laboratory procedures under aseptic procedures inside of a cleanroom
- Review batch records for proper completion.
- Manufactures the human tissue product AlloDerm as part of a production team
- Formally trained to execute laboratory procedures under aseptic procedures inside of a cleanroom
- Major contributor to Good Observations program
- Documented production information via daily system logs and discussed issues with management.
- Used equipment properly to avoid workplace hazards or injuries.
- Developed strong communication channels with team members, fostering a collaborative work environment that resulted in improved processes.
- Boosted team productivity by training new hires and cross-training existing employees on multiple tasks.
- Handled raw materials efficiently, minimizing waste during production process.
Set up and adjusted equipment and properly configured machines for daily operation. - Met production targets and tight deadlines by collaborating closely with team members.
Product Development Engineer
UNILIFE CORPORATION
01.2014 - 04.2015
- Developed test methods and wrote associated documentation for quality assurance and DHF in accordance with GMP and ISO standards
- Formalized documents for approval and validation to conclude that products were functional and consistent
- Currently being used for Quality Assurance testing of incoming components
- Validated test methodologies for consistency and accuracy
- Performed statistical analysis of test data using Minitab.
Education
Master of Science - Biomedical Engineering
New Jersey Institute of Technology
Newark, NJ12.2013
Bachelor of Science - Biomedical Engineering
New Jersey Institute of Technology
Newark, NJ06.2012
Skills
- SAP
- Oracle
- TrackWise
- GDP (Good Documentation Practice)
- Change Control
- Technical Writing
- Visual Inspection
- Quality Control
- Inspection protocols
- Training and mentorship
- Specifications reading
- GMP Knowledge
- Raw Materials Inspection and Testing
- Rejected Materials Disposal
- Attention to Detail
- Sampling procedures
Timeline
Quality Control Inspector II
AbbVie
02.2019 - 10.2024
Production Operator II
Allergan
04.2016 - 02.2019
Production Operator I
Lifecell as a temp through Kaztronics
09.2015 - 04.2016
Product Development Engineer
UNILIFE CORPORATION
01.2014 - 04.2015
Master of Science - Biomedical Engineering
New Jersey Institute of Technology
Bachelor of Science - Biomedical Engineering
New Jersey Institute of Technology
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