Kelly Woods
Quality Assurance & Regulatory Professional
Big Lake,MN
Summary
Forward-thinking Senior Specialist equipped with advanced operational and technical knowledge in Pharmaceutical and Medical Device Quality Assurance. Proven team leader and problem-solver competent in navigating complex situations with high collaboration and effective communication. Manages assignments, schedules and projects with organized and detail-oriented mindset.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Quality Assurance Senior Specialist
Teleflex
Maple Grove, MN
06.2021 - Current
- Quality approver and SME for Blood Product eQMS workflows (CO, NCE, CAPA, DDA) and QMS documents.
- Manage (create/enhance, implement, maintain) training program and change management program for cross functional Blood Products departments.
- Trainer for recurring and new hire training (GMP, GDP, QMS, CM).
- Identify and resolve quality issues using problem-solving skills, in consultation with other cross functional departments.
- Drive change through quality-oriented strategies to help operations accomplish ambitious short- and long-term goals.
- Model effective and constructive communication behaviors between department heads, low-level staff and senior leaders to improve cross-functional collaboration.
Quality Assurance Systems Specialist
Upsher-Smith Laboratories
Maple Grove, MN
03.2020 - 06.2021
- Managed and coordinated for workflows within eQMS and qQMS (e.g Veeva, SAP).
- Executed QA approval for the following (SOPs, CAPAs, Specifications, SAP IPs, APRs, CC).
- Lead and contributed to functional groups in execution of quality systems workflows (Veeva (CC, CAPA, DEV, SOP, SPEC) and SAP (Quality Module)).
- Created and conducted training for the Quality Document/Management system to use across the company.
CMC Regulatory Writer
Upsher-Smith Laboratories
Maple Grove, MN
01.2018 - 03.2020
- Authored CMC related technical data from Module 3 that support regulatory CMC submissions.
- Collaborated with subject matter experts to write and edit analytical documents, and other manufacturing related controlled technical documents.
CAS Systems Specialist (I, II, Senior)
Upsher, Smith Laboratories
Maple Grove, MN
02.2013 - 01.2020
- Provided leadership and technical expertise regarding technical writing, submission report documentation, safety and compliance issues.
- Managed the stability program, writing stability protocols, labeling, placing stability samples in the designated storage conditions, stability chamber inventory and removing stability samples from the chambers for testing.
- Technical Expert and Trainer for eQMS (SAP, SLIM, EDMS, VEEVA) for Chemistry and Analytical Sciences department.
- Identified, managed and implemented continuous improvement projects for company wide operational excellence initiatives.
- Created submission documents for CMC IND, NDA and ANDA projects.
Quality Assurance Auditor II
Perrigo Company
Plymouth, MN
10.2010 - 02.2013
- Reviewed testing documentation, method validations/transfers, investigations, equipment calibration/maintenance, raw material, product and stability, contract laboratories testing, vendor validations, standard qualifications, empower custom calculations along with GC and LC work.
- Performed 5S and Safety audits for QC Lab.
- Trained employees on GDP, empower scientist and reviewer roles.
- Worked with management to improve the quality and consistency of testing documentation with ongoing creation and revision of directive documents.
Chemist
Paddock Laboratories
Plymouth, MN
01.2009 - 10.2010
- Led commercial raw material group to schedule and monitor testing and release high priority products.
- Performed specialized testing (USP, HPLC and GC) and method validation/verification for new products.
- Collaborated in cross-functional management meetings to maintain the commercial production schedule.
- Led lab safety committee in quarterly audits along with implementation of chemical inventory.
- Trainer for equipment, techniques, instrumentation methods and all safety subjects (hazardous waste handlers, respiratory fit tests, EHS requirements).
Lab Analyst
Paddock Laboratories
Plymouth, MN
04.2008 - 01.2009
- Performed routine QC chemistry and daily in-process testing.
- Implemented new organization and tracking system to ensure materials are released on time.
- Ordered and maintain all materials for QC chemistry allowing lab to test products in a timely manner.
- Wrote deviations, revise methods and inspection plans as needed to ensure compliance.
Pharmacy Technician I and II
Health Partners Cent. MN Clinic & Village Pharmacy
Sauk Rapids, MN
08.2005 - 03.2008
- Performed routine medication processing with consistent results in a very fast paced environment.
- Conducted complaint electronic pharmaceutical insurance billing for all medications.
- Maintained an accurate inventory with monthly audits of all drugs including controlled substances.
Assistant Manager
Petters Warehouse
Waite Park, MN
05.1999 - 12.2006
- Managed up to 10+ employees open to close for all business operations.
- Conducted daily sales accounting
- Lead team that received, processed and displayed all inventory in a fast paced retail setting.
- Provided excellent customer service with using great problem solving and conflict resolution skills
Education
B.S - Biomedical Sciences and Chemistry
Saint Cloud State University
Saint Cloud, Minnesota05.2005
Skills
- Self Motivated
- Detail Oriented
- High Collaborator
- Effective Communicator
- Problem Solver
- Quality Minded
- Systems (Agile, Compliance Wire, VEEVA, SAP, JMP, EDMS, SLIM, Empower, Track Wise, Access, Microsoft Office (Word-Advanced))
Certification
- Six Sigma Green Belt
- ASQ Member
- RAP Accredited
- Situational Leadership
- The Art of Conflict Resolution
- Myers Briggs Indicator Type
Timeline
Quality Assurance Senior Specialist
Teleflex
06.2021 - Current
Quality Assurance Systems Specialist
Upsher-Smith Laboratories
03.2020 - 06.2021
CMC Regulatory Writer
Upsher-Smith Laboratories
01.2018 - 03.2020
CAS Systems Specialist (I, II, Senior)
Upsher, Smith Laboratories
02.2013 - 01.2020
Quality Assurance Auditor II
Perrigo Company
10.2010 - 02.2013
Chemist
Paddock Laboratories
01.2009 - 10.2010
Lab Analyst
Paddock Laboratories
04.2008 - 01.2009
Pharmacy Technician I and II
Health Partners Cent. MN Clinic & Village Pharmacy
08.2005 - 03.2008
Assistant Manager
Petters Warehouse
05.1999 - 12.2006
B.S - Biomedical Sciences and Chemistry
Saint Cloud State University