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
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
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
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
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
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
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
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
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
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