Shawana Smith
Quality Assurance Associate Manager
Rex,GA
Summary
Detailed-oriented and analytical professional with extensive experience in quality assurance, regulatory compliance, and data accuracy in the healthcare 3PL sector. Skilled in root cause analysis, and reporting tools such as 5 Whys, Fishbone, Cause Mapping, and other Root Cause Tools.
Quality Assurance Manager within a 3PL Healthcare facility to apply my strong analytical and problem-solving skills to drive informed decision making in a collaborative environment. To establish a position with an organization that has growth potential, where I can work toward achieving more knowledge and experience while strengthen my Managerial skills. Utilizing my professional leadership skills to help in developing standard policy and procedure within the company guidelines.
Overview
19
19
years of professional experience
Work History
Quality Assurance Associate Manager
UPS Healthcare
08.2020 - Current
- Audited and analyzed process data to ensure compliance with FDA and ISO standards.
- Documented and validated data for regulatory reporting and implemented continuous improvement strategies.
- Host Internal, External, Regulatory and client audits.
- Collaborate with cross-functional teams to identify potential quality issues and develop corrective action plans.
- Oversee documentation and reporting, ensuring adherence to company SOPs and regulatory requirements.
- Lead root cause analysis for deviations, non-conformances, and complaints, ensuring timely resolution and preventative actions.
- Implement continuous improvement initiatives that resulted in reduction in process deviations and non-conformities.
- Documented and investigated any deviations, implementing CAPA (Corrective and Preventative Actions).
- Ensure compliance with the regulatory requirements and to ensuring compliance of the Healthcare Quality System across four site Distribution Centers in three states, North Georgia, North Carolina, and Texas.
- December 2023 – Present Designated Representative for 3PL Distribution Center – Duluth, GA
- Responsibilities include, but not limited to, managing, or supervising the recordkeeping, storage, and distribution of drugs, devices, and controlled substances.
- Training, overseeing, and Monitoring completion daily, weekly and Monthly Tasks within the Quality System.
- Weekly Quality Working Committee (QWC) Meetings to include Key Performance Indicators (KPI), facility trends with the support of site Support Functions (Operations, FUR Support, site Plant Engineers).
- Managing multiple client audits, daily communications, and feedback.
- Completion of site investigations to determine root cause, corrective actions and determining if any risk is involved at the site level.
- Compose Weekly, Monthly, and Bi-annual Quality Management System Metrics for Senior Healthcare Compliance Reviews.
- Develop and update client specific procedures, including distribution, inventory control, receiving, returns and disposals.
- Monitor expiration dates and arrange for disposal of expired and damaged products.
- Completion of site (Global Trainings and GxP Training).
- Conducting New Hire Training via Classroom or One-to-One, teaching work methods and procedures for accomplishing a systematic approach for all employees.
Healthcare Quality Assurance Supervisor
UPS Healthcare
02.2012 - Current
- Maintain the Quality System for two Healthcare Distribution Centers, Duluth, and Suwanee.
- Responsibilities include, but were not limited to, managing, or supervising the recordkeeping, storage, and distribution of drugs, devices, and controlled substances.
- Maintain and provide inventory records needed for support in internal and external UPS and client audits.
- Monitor expiration dates and arrange for disposal of expired and damaged products.
- Work with clients to resolve inventory and shipping issues.
- Develop and update client specific procedures, including distribution, inventory control, receiving, returns and disposals.
- Ensure adherence to FDA/DEA and various other governmental regulations.
- Conduct facility meetings concerning all aspects of the daily operations including safety and pest control.
- Assist with internal, client, and several local agency audits. (FDA and DEA)
- Assist in assessing the risk and compliance implications of client products.
- Communicate Quality Policy and ensure documented objectives are met timely.
- Provide customer complaint investigations to clients.
- Prepares and assist with internal audits and validation of the Quality System and participates in assessing the risk and compliance of the client's products.
- Prepares training to conduct quality training for personnel.
- Responsible for control of Non-Sellable Products as per approved procedures to prevent distribution to the market.
- Supports Operations and make recommendations for quality and efficiency improvements.
- Timely report nonconformance's which may adversely affect product or process quality.
- Comply with all applicable regulations to safeguard product quality and patient safety.
Healthcare Quality Assurance Specialist
UPS Supply Chain Solutions
01.2007 - 01.2012
- Maintain the Quality System for two Healthcare Distribution Centers.
- Assist with internal, client, and several local agency audits. (FDA and DEA)
- Responsibilities include, but are not limited to, managing, or supervising the recordkeeping, storage, and distribution of drugs, devices, and controlled substances.
- Assist in assessing the risk and compliance implications of client products.
- Communicate Quality Policy and ensure documented objectives are met timely.
- Provide customer complaint investigations to clients.
- Prepares and assist with internal audits and validation of the Quality System and participates in assessing the risk and compliance of the client's products.
- Prepares training to conduct quality training for personnel.
- Responsible for control of Non-Sellable Products as per approved procedures to prevent distribution to the market.
- Supports Operations and make recommendations for quality and efficiency improvements.
- Timely report nonconformance's which may adversely affect product or process quality.
- Comply with all applicable regulations to safeguard product quality and patient safety.
Education
Some College (No Degree) - Business Administration And Management
Phoenix University Online
Phoenix, AZBusiness Administration And Management
Atlanta Area Tech College
Atlanta06.2007
High School Diploma -
D. M. Therrell High School
Atlanta, GA01.1994
Skills
- Database Tools and Platforms
- VeevaVault
- Power BI
- ISO 9001:2015
- ISO 13485-2016
Training and mentoring
Customer complaint handling
Problem-solving skills
Data analysis
Analytical thinking
Documentation and reporting
Quality assurance
Warehouse operations
Team collaboration
Team leadership
Decision-making
Verbal and written communication
Internal audits
Quality improvements
Quality management systems
Public speaking
Risk management
Correction action planning
Employee supervision
Employee training
Strong work ethic
QMS
Effective multitasking
Process documentation
Interpersonal communication
Corrective action planning
Cross-functional teamwork
ISO standards
Languages
English
Full Professional
Timeline
Quality Assurance Associate Manager
UPS Healthcare
08.2020 - Current
Healthcare Quality Assurance Supervisor
UPS Healthcare
02.2012 - Current
Healthcare Quality Assurance Specialist
UPS Supply Chain Solutions
01.2007 - 01.2012
Some College (No Degree) - Business Administration And Management
Phoenix University Online
Business Administration And Management
Atlanta Area Tech College
High School Diploma -
D. M. Therrell High School
Training
- 2012- Completion of QA/RA Orientation- 4 days; Louisville, KY
- 2007- Completion of QA/RA Orientation- 4 days; Louisville, KY
- 2000- Client Training- 8 weeks; Plano, Texas
- 1999- Inventory and Destruction of client product- 4 weeks; Memphis, Tennessee
- Qualified Trainer on Standard Operating Procedures (SOPs), Good Manufacturing Practices (cGMPs), and Client Work Instructions
- 2008-2011 Wholesale Drug Distributor Designated Representative (DR)- UPS Supply Chain Solutions- Decatur, GA Distribution Center
- 2012-2014 Wholesale Drug Distributor Designated Representative (DR)- UPS Supply Chain Solutions- Suwanee, GA Distribution Center
- 21 CFR Part 11 Training
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