Jennifer Folden
Spencer,IN
Summary
Accomplished Quality Assurance professional with 11 years of expertise in pharmaceutical and medical manufacturing, focusing on aseptic quality oversight and FDA/cGMP compliance. Experienced in managing batch record documentation, conducting cleanroom monitoring, and providing GxP training to ensure audit readiness and continuous improvement. Proficient in TrackWise, Salesforce, ERP systems, and Microsoft Office Suite, with a Lean Six Sigma Yellow Belt certification.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Quality Associate I – Operations
Singota Solutions
02.2023 - Current
- Ensured contamination control by conducting aseptic gowning observations and checks.
- Supported audit readiness by compiling and trending batch documentation data.
- Maintained QA compliance by overseeing Manufacturing, SCM, and QC team operations.
- Verified SCM materials and documentation accuracy, ensuring cold-chain compliance.
- Established operational standards by authoring Manufacturing Material Specification Sheets (MMS).
- Contributed to internal audits and CAPA implementation through deviation investigations.
Quality Assurance Technician
Catalent Pharma Solutions
07.2022 - 02.2023
- Supported deviation investigations, documentation control, and batch record corrections.
- Managed TOCS and controlled forms to maintain data integrity.
- Maintained organized Master Batch Record files to uphold regulatory compliance and ensure traceable documentation.
Manufacturing Operator
MFG Staffing / Catalent Pharma Solutions
07.2021 - 07.2022
- Operated drug substance formulation equipment under cGMP protocols.
- Supported batch documentation and equipment calibration to ensure production continuity.
- Maintained GMP compliance in aseptic ISO 9001 cleanroom operations.
Quality Assurance Representative
Bloom Insurance Agency
11.2019 - 07.2021
- Conducted QA evaluations and implemented workflow improvements.
- Supported documentation accuracy and cross-department compliance.
Assembler / Production & Machine Operator
Cook Medical
01.2008 - 01.2016
- Built and inspected medical products in cleanroom environments.
- Led sub-assembly teams and contributed to SOP improvements.
Education
Associate of Science - Early Childhood Education
Ivy Tech Community College
Bloomington, IN05.2019
High School Diploma - undefined
Edgewood High School
Ellettsville, IN05.2007
Skills
- Aseptic Gowning & Quality Oversight
- Integrity of documentation review
- GxP Training & Program Development
- TrackWise, Salesforce, ERP Systems, Microsoft Office Suite
- Supply chain management oversight
- Authoring & Maintaining MMS
- Quality management system
- CAPA management
- Documentation review
- Supplier quality
- Product inspection
- Internal auditing
Certification
- Lean Six Sigma Yellow Belt – GoSkills
- Technical Writing for Quality Professionals – CfPIE
- Business Writing, Project Management, Emotional Intelligence, Time Management, Microsoft Excel 365
Timeline
Quality Associate I – Operations
Singota Solutions
02.2023 - Current
Quality Assurance Technician
Catalent Pharma Solutions
07.2022 - 02.2023
Manufacturing Operator
MFG Staffing / Catalent Pharma Solutions
07.2021 - 07.2022
Quality Assurance Representative
Bloom Insurance Agency
11.2019 - 07.2021
Assembler / Production & Machine Operator
Cook Medical
01.2008 - 01.2016
High School Diploma - undefined
Edgewood High School
Associate of Science - Early Childhood Education
Ivy Tech Community College