Summary
Overview
Work History
Education
Skills
Timeline
Accomplishments
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Traci Waldecker

Quality Assurance Leader
Falling Waters,WV

Summary

Focused professional knowledgeable about devising innovative solutions to diverse business concerns and goals. Strategic and forward-thinking leader with self-motivated and tactical mindset. Excellent relationship-building and critical thinking skills with determined and decisive nature.

Overview

26
26
years of professional experience
6
6
years of post-secondary education

Work History

Site Annual Product Quality Review Coordinator

Procter And Gamble
Inwood, West Virginia
09.2022 - Current
  • Compile and analyze data from a variety of sources such as SAP, technical specifications, consumer complaints and adverse events.
  • Complete reports on a monthly basis to assess performance of materials and processes established to deliver the intended product quality.
  • Formally assess need for changes in drug product specification, materials and manufacturing and control procedures.
  • Obtain required reviews and approvals within the required timeframes.
  • Distribute approved reports to internal and external regulatory agencies when requested.
  • Assist in validation of additional making/packing systems. Currently oversee 3 drug lines that produce 7 drug chassis.
  • Proved successful working within tight deadlines and a fast-paced environment
  • Passionate about learning and committed to continual improvement
  • Paid attention to detail while completing assignments
  • Identified issues, analyzed information and provided solutions to problems

Site Stability Coordinator

Procter And Gamble
Inwood, West Virginia
09.2022 - Current
  • Establish, document and ensure drug products maintain their quality, efficacy and safety during use under various environmental storage conditions.
  • Ensure representative marketed samples are maintained and tested throughout the shelf life of the product.
  • Provide necessary data to support New Drug Applications submissions
  • Have overall responsibility for planning, documenting, placing, testing all stability samples and reporting results.
  • Overall responsibility to ensure proper documentation in R&D/plant stability protocols are complete, compliant and correct prior to execution.
  • Work Process improvements have driven a 75% reduction in samples required and $750,000 cost saving/avoidance
  • Self-motivated, with a strong sense of personal responsibility
  • Managed time efficiently in order to complete all tasks within deadlines
  • Organized and detail-oriented with a strong work ethic
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations
  • Adaptable and proficient in learning new concepts quickly and efficiently
  • Gained extensive knowledge in data entry, analysis and reporting

Beauty Care Raw and Pack Materials Leader

Procter And Gamble
Inwood, West Virginia
01.2018 - 09.2022
  • Assured over 500 new and existing materials brought to the site are from qualified suppliers with good quality history.
  • Ensured supplier quality management is tracked and maintained and can produce records and reports for regulatory agencies.
  • Confirmed all performance characteristics listed on technical standards can be tested on site.
  • Implemented mitigation plans for supplier that have become higher risk.
  • Approved all changes to raw material testing status.
  • Developed and implemented process improvements to reduce costs and increase efficiency receipt, sampling, testing and release of starting materials.
  • Designed procedures by which all starting materials are sampled, evaluated and dispositioned during start-up of the site. These procedures drove a 50% reduction in release timing.
  • Trained and qualified site disposition team for release of raw materials as well as highly regulated finished products
  • Developed process to track age control of bulk storage tanks.
  • Wrote and ensured required quality assurance technical agreements were in place.
  • Assist regulatory agencies with all material related inquiries as the subject matter expert for the site.
  • Gained strong leadership skills by managing projects from start to finish
  • Assisted with day-to-day operations, working efficiently and productively with all team members
  • Resolved problems, improved operations and provided exceptional service
  • Demonstrated respect, friendliness and willingness to help wherever needed
  • Developed strong communication and organizational skills through working on group projects

Unit Manager

Waffle House
Hagerstown, MD
01.2015 - 12.2017
  • Quickly identified problem situations and skillfully resolved incidents to satisfaction of involved parties.
  • Reconciled cash and credit card transactions to maintain accurate records.
  • Carefully interviewed, selected, trained, and supervised staff.
  • Promoted positive atmosphere and went above and beyond to guarantee each customer received exceptional food and service.
  • Conducted health, safety, and sanitation process evaluations to identify and remedy any violations immediately.
  • Oversaw front of house personnel to maintain adequate staffing and minimize overtime.
  • Met, greeted, and encouraged feedback from customers and used feedback to implement positive changes within restaurant.
  • Correctly calculated inventory and ordered appropriate supplies.
  • Reduced process bottlenecks by training and coaching employees on practices, procedures, and performance strategies.

General Manager

PetSmart
Sterling, VA
01.1997 - 01.2015
  • Recruited and retained top talent, with focus on completing timely performance evaluations, providing positive feedback, and rewarding superior performance.
  • Coached employees and trained on methods for handling various aspects of sales, complicated issues, and difficult customers.
  • Trained team members in successful strategies to meet operational and sales targets.
  • Submitted orders for new inventory.
  • Completed routine store inventories.
  • Managed inventory control processes to restore back stock, control costs, and maintain sales floor levels to meet customer needs.
  • Offered hands-on assistance to customers, assessing needs, and maintaining current knowledge of consumer preferences.
  • Maintained customer satisfaction with quick and professional handling of product returns.
  • Oversaw employee performance, corrected problems, and increased efficiency to maintain productivity targets.
  • Exceeded sales goals and accomplished business objectives by inspiring staff and promoting target products.

Education

Bachelor of Arts - Anthropology

University of Georgia
Athens, GA
01.1992 - 12.1997

Skills

SAP QM/PE expert

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Timeline

Site Annual Product Quality Review Coordinator

Procter And Gamble
09.2022 - Current

Site Stability Coordinator

Procter And Gamble
09.2022 - Current

Beauty Care Raw and Pack Materials Leader

Procter And Gamble
01.2018 - 09.2022

Unit Manager

Waffle House
01.2015 - 12.2017

General Manager

PetSmart
01.1997 - 01.2015

Bachelor of Arts - Anthropology

University of Georgia
01.1992 - 12.1997

Accomplishments

  • Ruby Award winner (CEO Award runner up) 2018, 2019 and 2020
  • CEO Award winner 2021
  • Steering committee member for two affinity groups
  • Site qualifier for multiple roles


Traci WaldeckerQuality Assurance Leader