Winsome Kirlew
Sunrise,FL
Summary
A highly motivated QA/QC Leader with a Master’s Degree, 10+ years of experience in the Dietary Supplement and Food Industries, and over 5 years’ experience, in Cosmetics and Personal Care. Possesses excellence in cGMP practices, regulatory compliance, auditing, and training with dynamic project management skills for successful synergy between R&D, Operations, Purchasing, and Marketing teams.
Notable achievements include: developing departments to ensure audit readiness, both in the department and across the company with a 95% success rate in external audits, as well as, implementing a state of the art FDA accepted testing process, resulting in 75% cost reduction and substantially improved efficiencies.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Quality (QA/QC) Manager
Life Extension Inc
03.2023 - 10.2023
- Conducted successful nationwide audits at contract manufacturers, as part of the supplier qualifications program, against ISO, NSF, and 21CFR 111 certifications.
- Supervised a quality team of 3 regarding documentation, including consumer complaints, investigation, change control, and KPI, while providing leadership and guidance.
- Directed the Stability Program.
- Managed the Annual Review for product and co-manufacturers.
- Liaised with consulting as a committee member for the Health Canada registration.
- Provided support to Purchasing, R&D, and contract manufacturers.
- Evaluated new materials and suppliers for compatibility with company requirements, making recommendations based on objective analysis.
Quality (QA/QC) Manager
Slate Solutions
09.2022 - 03.2023
- Strategized a successful 3rd party ISO 9001:2015 audit with the Government 2 months after joining by conducting a GAP analysis and expeditiously performing corrective action to ensure audit readiness.
- Created process improvements to the Quality department, doubling productivity.
- Designed and implemented multiple SOP, test methods, and process validation procedures.
- Introduced cross-training and GMP awareness in the quality department, successfully inspiring a team of 9 employees, while providing on-the-job training for select production teams, increasing productivity by 30%.
Quality (QA/QC) Manager
Anthem South
07.2019 - 08.2022
- Accommodated and formulated audits for regulatory agencies including ISO22716, OTC, FDA, FSC, state offices, and large cap clients while achieving over a 95% success rate.
- Devised timeline development, investigated success criteria, and conducted GAP analysis to spearhead a team of subject matter experts (SMEs) in preparation for OTC certification.
- Implemented new state of the art equipment (the rapid testing of microbes and environment testing) resulting in 75% cost savings in the laboratory
- Developed and prioritized quality functions to ensure compliance to the governing 21CFR 111.
- Provided product and process support to R&D, Marketing, Production, Logistics, and Procurement, as well as assisted with process validation procedures.
- Administered root cause analysis and corrective action (RCCA) and non-conformance investigations.
- Coordinated staff training and successfully developed a team of 15 diverse employees in the quality department resulting in effective cross-training and thinking outside of the box.
Global QA Manager
Stemtech Corporation
11.2014 - 03.2019
- Executed timely product registration in various markets (including Australia, Canada, Mexico Taiwan, Korea, and Malaysia) while coordinating each stage with the local consultant.
- Presided over the site license application for Canada ensuring alignment with policy and regulatory guidelines.
- Developed and prioritized quality functions to ensure compliance to the governing 21CFR, SOP writing, and various reporting systems such as consumer complaints and CAPA.
- Approved, sourced, and verified raw material, with alternate vendors, to assist the Operations department.
- Managed the stability program of over 15 products resulting in enhancement of shelf-life evaluation.
- Audited contract manufacturing facilities and warehouses at scheduled intervals, both locally and internationally, resulting in an average 25% increased efficiencies
- Authorized product introduction, rework, and product related investigation by coordinating with R&D and contract manufacturers.
- Monitored products drop shipped by performing third party testing and evaluation against standard specification and COA.
- Reviewed the label, web material, and printed package through a sign-off process, prior to publishing phase.
- Strategized in planning meetings between departments, such as R&D, Operations, and Marketing.
- Coordinated support to Research & Development department in clinical studies by applying scientific principles including monitoring testing, project management, and report evaluation.
- Instructed all staff members on general procedures in addition to area specific training for quality, warehouse, and customer service personnel to support team performance and skill set development.
Quality (QA/QC) Manager
Vital Pharmaceutical
03.2009 - 05.2014
- Developed a quality department from one chemist and a shared Production/QC Inspector to a team of 15.
- Established and prioritized quality functions to ensure compliance to the governing 21CFR 111, SOP writing, various reporting systems such as CAPA, consumer complaints, nonconformance, deviations, and recalls.
- Orchestrated two successful FDA audits and responses, including writing SOPs, training the staff with mock audits, walking with auditors, and writing the responses.
- Managed the stability program of over 20 products resulting in enhancement of shelf-life evaluation.
- Oversaw consumer complaints and adverse events, from intake, through investigation and ensuing response.
- Effectively managed the site license application for Australia and Canada, as well as the audit from Australia, resulting in product launch in both countries.
- Directed a team of subject matter experts (SMEs) to prepare for NSF certification.
- Delivered well-planned support to product introduction, rework, and product related investigation.
- Audited contract manufacturing facilities and warehouses at scheduled intervals resulting in at least 25% increased efficiencies based on mutual expectations.
- Negotiated and implemented detailed, yet concise quality agreements for both contract laboratories and manufacturers, oftentimes including detailed audit reviews.
- Implemented closely monitored policies for the laboratory including testing cost and skip lot testing, resulting in 25% cost savings.
- Effected root cause analysis and corrective action (RCCA) to identify issues, assess impact, and resolve events.
- Trained, motivated, and successfully oversaw a team of 15 diverse employees in the quality department resulting in effective cross training and 4 promotions in 2 years.
Sanitation and Safety Specialist
Florida Department of Agriculture and Consumer Services
04.2001 - 03.2009
- Conferred with industry officials about food safety and regulatory matters through auditing and promotion of the Food Code, HACCP principles, and 21 CFR 111, exceeding the monthly requirement.
- Accomplished functions in the capacity of an FDA Officer as required.
Education
Master of Science in Information Systems & Operations Management (MIS: OM) -
Nova Southeastern University
Davie, FLExecutive And Supervisory Management Program -
The University of The West Indies
Kingston, JamaicaBachelor of Science in Chemistry, Minor in Accounting -
The University of The West Indies
Kingston, JamaicaSkills
- Project Management
- Vendor Qualification
- Data Analysis
- Risk Management
- Audit Readiness
- Microsoft Office Suite
- Go-to-Market Strategies
- Employee Management
- Failure Analysis
- Timeline Development
Locations
- Sunrise, FL, 33323
- Durham, NC, 27703
Certification
- CQA
- HACCP
- PCQI
Regulatory Experience
- FDA
- EPA
- OTC
- ISO 22716: 2007
- ISO 9001: 2015
Industry Experience
- Dietary Supplement: 10+ years
- Cosmetic and Personal Care: 5+ years
- Food: 8+ years
- Pet Food: < 1 year
Consulting Experience
Quality QA/QC Consultant
2019 – Present
Food Industry:
- Composed SOPs for catering services.
Dietary Supplement Industry:
- Sourced, audited, and approved suppliers and contract manufacturers from 2019 – 2021.
- Scheduled and monitored production, then organized logistics procedures.
- Reviewed and approved documentation including COAs.
- Wrote SOPs and assisted R&D as needed.
Pet Snacks and Treats Industry:
- Performed audits to improve process flow and improve efficiencies.
- Drafted SOP’s against 21CFR 111.
Timeline
Quality (QA/QC) Manager
Life Extension Inc
03.2023 - 10.2023
Quality (QA/QC) Manager
Slate Solutions
09.2022 - 03.2023
Quality (QA/QC) Manager
Anthem South
07.2019 - 08.2022
Global QA Manager
Stemtech Corporation
11.2014 - 03.2019
Quality (QA/QC) Manager
Vital Pharmaceutical
03.2009 - 05.2014
Sanitation and Safety Specialist
Florida Department of Agriculture and Consumer Services
04.2001 - 03.2009
Master of Science in Information Systems & Operations Management (MIS: OM) -
Nova Southeastern University
Executive And Supervisory Management Program -
The University of The West Indies
Bachelor of Science in Chemistry, Minor in Accounting -
The University of The West Indies
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