BRITTNEY WOJTASZEK
Alto,MI
Summary
Dynamic Supplier Quality leader with over 13 years of experience in the pharmaceutical industry, specializing in packaging materials and medical devices. Proven track record in driving supplier excellence, mitigating risks, and ensuring compliance across cross-functional teams. Energized by proactive problem-solving and the cultivation of trusted supplier relationships, committed to championing quality practices that protect patients and inspire progress.
Overview
19
19
years of professional experience
Work History
Manager Lab Operations - Supplier Quality
Pfizer
Kalamazoo, MI
01.2022 - Current
- Manage and maintain effective relationships with suppliers to ensure quality, timely delivery, and compliance with company standards for packaging materials and medical devices.
- Support and coordinate the team of incoming inspectors, ensuring efficient inspection workflows and compliance with standards
- Collaborate with multiple internal stakeholders, including Procurement, Operations, Regulatory, Packaging Engineering, etc. to drive projects and resolve issues.
- Supplier Correct Action Request (SCAR) representative and co-creator for the Kalamazoo site, utilized globally by Pfizer.
- Utilize systems such as QTS, SAP, eQMS, and gLIMS to track, document, and analyze material and quality data efficiently.
- Help lead activities for new packaging and medical device initiatives or changes to existing materials, ensuring timelines, budgets, and quality standards are met.
- Support evaluation and qualification of new materials, including risk assessments, test method development and validation, and performance testing which includes coordination of testing, documentation, and cross-functional approvals for new materials (or changes).
Senior Quality Specialist for Supplier Quality Incoming Packaging Materials
Pfizer
Kalamazoo, Michigan
01.2018 - 01.2022
- Transitioned from Quality Specialist to Senior Quality Specialist, focusing on improving product quality and compliance standards.
- Directed oversight of incoming inspection group, ensuring compliance with quality standards for primary and secondary materials.
- Achieved successful implementation of global scar team module in QTS, streamlining supplier complaint management across Pfizer. Delivered comprehensive training and developed standard operating procedures for Kalamazoo site. Facilitated phased rollout, resulting in improved complaint resolution processes.
- Initiated collaborative discussions with planners and inspectors to optimize practices for meeting production supply and demand requirements.
- Responsible for the complaint communications to the suppliers for both Incoming and Production issues
- Executed skip lot testing for hydrolytic resistance, confirming vendor results and achieving over $300,000 in cost reductions for the company.
- Represented supplier quality group during supplier visits to ensure compliance with quality standards.
Microbiologist for Sterilization Technology
Pfizer
Kalamazoo, Michigan
01.2015 - 01.2018
- Subject matter expert in both Dry Heat Sterilization and Vaporized Hydrogen Peroxide with knowledge in Steam Sterilization and Terminal Sterilization.
- Responsible for executing initial validations on new pieces of equipment at the site, including, but not limited to: 3 APS Prep Dry Heat Ovens, 1 Bio Ops Depyrogenation Oven, 2 VHP generators, and supporting the Sterile Suspension project with another VHP generator and the ChargePoint Valve
- Worked to increase use of the VHP Pass-Through chamber to decrease reliance on air-lock sanitization of items entering APS
- Performed annual requalification studies on: APS Prep Ovens, Gelfoam Ovens, Endotoxin Lab Oven, Hulls Freeze Dryers, VHP generators, VHP Pass-Through Chamber, and the Greer Mill
Varsity Volleyball Coach
Loy Norrix High School
Kalamazoo, Michigan
01.2014 - 01.2016
- Responsible for oversight of the volleyball program at all 3 levels: freshman, junior varsity, and varsity
- Organized fundraising events to support program needs and foster community engagement.
- Organized off-season conditioning programs, preparing athletes for peak performance during competition season.
- Built strong relationships with parents and guardians, fostering open lines of communication regarding player progress and expectations.
Endotoxin Lab Analyst/Aseptic Plant Support
Pfizer
Kalamazoo, Michigan
01.2013 - 01.2015
- Trained to perform and analyze the following endotoxin tests: gel-clot, kinetic chromogenic, kinetic turbidimetric, special studies, and the validations
- Led an on-going endotoxin project pertaining to packaging and sundry items for the site – items that have product contact and/or are part of the product pathway
- Unit Trainer responsible for entering, updating, enrolling/removing colleague’s training
- Understands aseptic laboratory techniques and the importance of sanitization and sterilization
- Discovered positive results in steps of a CSAV study where lab error was ruled out and a lab investigation was conducted
- Introduced the possibility of glucan inhibition and initiated testing with the idea to use Glucashield, which is a beta-glucan blocker; developed a protocol for the use of Glucashield
- Received recognition for the work on the CSAV study; the extremely tight timeline along with my efforts allowed the project to continue its steps in the process of getting this life saving product back on the market
API Training Specialist
Pfizer
Kalamazoo, Michigan
01.2012 - 01.2013
- Supported specific API units with the training group
- Responsible for new colleague and contractor orientation training while leading, initiating, and monitoring current training
- QTS responsible person which entailed authoring, updating, and entering documents into the system; engaged with unit SMEs to create new job aids, OJTs, SOPs, etc.
Clinical Department Assistant/Marketing/ Inside Sales
Carelinc Home Medical Equipment & Supply
Grand Rapids, Michigan
01.2007 - 01.2012
- Supported sales, marketing, and customer service objectives through daily interactions and key initiatives.
- Completed training and implementation of medical equipment including CPAP/BIPAP machines, apnea monitors, negative pressure wound therapy, food pumps, ventilators, pulse oximeters, etc.
- Improved add-on sales process while working with existing customers
- Developed forms included in the welcome packet for new CPAP/BIPAP customers
Education
Bachelor of Science - Microbiology
Michigan State University
East Lansing05.2010
Skills
- Team leadership
- Strong verbal and written communication
- Customer complaint handling
- CAPA management
- Quality management systems
- Quality metrics monitoring
- Decision-making
- Time management
- Electronic Systems: QTS, LIMS, gLIMS, SAP, eQMS, SMS, CLM
Timeline
Manager Lab Operations - Supplier Quality
Pfizer
01.2022 - Current
Senior Quality Specialist for Supplier Quality Incoming Packaging Materials
Pfizer
01.2018 - 01.2022
Microbiologist for Sterilization Technology
Pfizer
01.2015 - 01.2018
Varsity Volleyball Coach
Loy Norrix High School
01.2014 - 01.2016
Endotoxin Lab Analyst/Aseptic Plant Support
Pfizer
01.2013 - 01.2015
API Training Specialist
Pfizer
01.2012 - 01.2013
Clinical Department Assistant/Marketing/ Inside Sales
Carelinc Home Medical Equipment & Supply
01.2007 - 01.2012
Bachelor of Science - Microbiology
Michigan State University