Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
20
20
years of professional experience
Work History
Quality Associate II
Baxter
08.2021 - Current
Created plans to identify areas of risk including non-conformance
Determine the logic, adequacy, and effectiveness of processes and systems
Provides leadership for ongoing, daily departmental operations
Serve as a Subject Matter Expert(SME) by maintaining high level expertise for regulatory requirements
Identify training needs and organize training interventions
Training coordinator for the facility
Investigate customers complaints
Conduct audits of the facility for observation purposes
Knowledge of FDA regulations and guidelines.
Improved product quality by implementing rigorous inspection processes and providing feedback to production teams.
Enhanced customer satisfaction by addressing and resolving complaints in a timely manner.
Maintained open lines of communication with regulatory agencies, ensuring the organization remained in compliance with all applicable standards and industry regulations.
Supported the development of a positive quality culture within the organization through continuous education and communication efforts.
Quality Assurance Coordinator
INTERSTATE BLOOD BANK
08.2019 - 04.2021
Reviews all laboratory product test records
Assists with the preparation of and/or reviews equipment and/or software validation protocols
May perform the calibration needed in the laboratory
Assists laboratory management in the planning, implementation and follow-up of corrective action
Monitors the preventive maintenance program of laboratory instruments and equipment
Monitors for timely resolution of any error and/or accident reporting
Keeps Corporate Quality Assurance informed of quality concerns; serves as liaison between the laboratory and Corporate Quality Assurance and Regulatory Affairs
Performs other duties as may be required/assigned
Train production staff on quality procedures, protocols, and documentation
Develop the standard measurements for processes to be compared against.
Evaluated accuracy of existing quality assurance measurement techniques, implementing improvements to increase efficacy and reduce errors.
Conducted regular audits to identify areas of improvement, leading to increased customer satisfaction levels.
Improved product quality by implementing rigorous testing processes and protocols.
Served as a trusted advisor to senior management on matters related to quality assurance, contributing valuable insights that informed strategic decision-making processes.
Quality Laboratory Technician, Research Assistant
Sherwin Williams
05.2004 - 06.2005
Insure that products produced at the facility meet external and internal customers' quality standards
Responsible for the quality inspection and testing of all products
Conduct audits on finished goods
Entered test results into an electronic bench record
Tested data to determine specification center, range, etc
Maintained supply inventory for work areas
Prepared and reported daily analysis to Research and Development
Performed standardized test in compliance with EPA, FDA, internal specifications.
Optimized workflow within the lab by reorganizing workspaces and implementing best practices in sample management.
Implemented new testing procedures to streamline efficiency, resulting in a significant reduction in processing time.
Provided expert guidance on quality control issues, leading to effective problem-solving and timely resolutions.
Enhanced product quality by conducting thorough laboratory tests and analyzing results for improvements.
Education
B.S. in Chemistry -
05.2004
Skills
10 Key Calculator
Microsoft Word
Microsoft Excel
Trained Medical Coder
Strong Customer Service
Calibration (10 years)
GLP (8 years)
Manufacturing (6 years)
Quality Control (8 years)
Quality Inspection (8 years)
MDS (1 year)
Laboratory Management
Microsoft SharePoint
ICD-10
Internal Audits
Root cause analysis
Contract (9 years)
Data collection (4 years)
Writing Skills
Quality Assurance
Employment & labor law
Supervising experience
Analysis skills (3 years)
Office experience
FDA regulations
TCU (3 years)
Track wise (3 years)
Warehouse management system (3 years)
Problem-solving skills
Team Collaboration
Team Leadership
Manual Testing
Quality Training
Quality Management System
Quality Metrics
Documentation Review
Internal Auditing
Process Validation
Product Inspection
Techniquesandskillsmastered
Wet Chemistry Analysis Methods
Titrations
Solvent extractions
Distillation
Viscosity
PH testing
Safety precautions in the laboratory
Product integrity and product safety
Sampling techniques
Standard units of measurement
Intense record and data keeping
Handling glassware
Personal
Can provide strong personal and professional references upon request