Dedicated Quality Assurance Specialist with twenty one years experience in the Pharmaceutical Industry. Proven ability to identify, analyze and problem solve.
Extensive knowledge in FDA regulations, GMP's and vital/critical record protection requirements.
Overview
25
25
years of professional experience
Work History
Team Associate
Walmart
02.2024 - 12.2024
Kept work areas clean, organized, and safe to promote efficiency and team safety.
Contributed to team success by completing jobs quickly and accurately.
Trained new team members by relaying information on company procedures and safety requirements.
Created appealing displays for routine arrangements and special promotions.
Pursued learning opportunities to advance knowledge and take on leadership position.
Resolved issues quickly to maintain productivity goals.
Worked different stations to provide optimal coverage and meet production goals.
Operated register to process payments and collect cash payment for order totals.
Developed strong customer service and product knowledge skills to enhance individual and team performance.
Team Mentor - Resident Care Assistant
Our House Senior Living
03.2023 - 01.2024
Assisted with activities of daily living according to unique care plans
Responsible to track and chart data daily in line with company expectations
Implemented individual care plans as written
Collaborated with residents/family in establishing mutual goals based on the resident needs or problems
Monitored and recorded resident response to care according to individualized care plan
Lead and motivated peers for improvement in standard work
Documented any observed changes in the resident’s condition
Administered medications to residents
Provided guidance, support, and training to new employees
Assisted in evaluating overall performance of employees
Web Order Processor
Lands’ End
09.2022 - 01.2023
Ensured web orders placed online by customers were accurate before releasing to fulfillment status
Collaborated with the Art department to customize logos per customer requirements
Made outbound calls to customers to clarify additional information to finalize orders
Delivered outstanding customer service
Monitored and tracked inventory to achieve prompt order fulfillment.
Updated company tracking system with latest information.
Product Complaint Analyst 1
AbbVie, Inc. (Formerly Abbott Laboratories)
03.2015 - 11.2021
Ensured product quality complaints, potential adverse events and potentially reportable events are handled accordingly and in a timely manner
Provided quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product
Created and provided customer letters that address the outcome of investigations performed
Summarized and closed each assigned product quality complaint after appropriate tasks are complete
Initiated and assigned investigation tasks to appropriate functional area
Monitor tasks to ensure they are complete within the given timeline
Responsible for tracking and trending of five pharmaceutical products on a monthly basis
Interfaced with TPM and TPC’s, health care professionals, general public, internal customers, Abbvie functional areas and regulatory agencies
SME for Mavyret (product used for Hepatitis B treatment)
Supported internal and external audits
Collaborated and implemented process change through continuous improvement
Records Analyst
AbbVie, Inc. (Formerly Abbott Laboratories)
01.2007 - 01.2015
Initiated change request documents and generated reports in the Quality Document Management System (QDMS)
Consulted and conducted training to Department Managers and Record Coordinators on AbbVie Record Retention Schedule updates, record classification and vital/critical record protection requirements
Classified records, legal hold orders and created inventory of records in Facility Closures and Divestitures
Assisted in system decommissions to ensure that all records housed in the applicable system have met retention requirements per AbbVie Records Retention Schedule
Senior Records Information Coordinator
AbbVie, Inc. (Formerly Abbott Laboratories)
01.2000 - 01.2007
Generated metrics used to determine inefficiencies and areas for improvement
Documented process flows and developed requirements for functional improvements and enhancements to Abbott Record Centers
Responsible for retrieving records requested by the FDA and other agencies during audits in a timely manner
Developed and implemented a network of coordinators responsible for managing company records