Sheron Renae Blackwell
Greensboro,NC
Summary
Qualifications Summary
6 years as Senior Quality Systems Specialist
3 years as Senior Quality Scientist
12 years as Microbiology and Urinalysis Supervisor
11 years as Medical Technologist in Microbiology
4 years as Virology Supervisor
Highly productive self-starter with excellent interpersonal and communication skills
Committed to demonstrating professional excellence and serves as a role model of quality assurance
Can efficiently multi-task and is proficient with Microsoft Applications
Able to work well with others
Able to adapt quickly to change
Meticulous attention to detail
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
21
21
years of professional experience
Work History
Sr. Quality Systems Specialist
IDAST
Sparks, MD
05.2019 - Current
- Responsible for data collection, data coordination, and remediation of IDAST stability testing for In Vitro Diagnostic Regulation (IVDR) technical file submissions
- Responsible for creation of reports to support IVDR technical file submissions
- Responsible for coordination, investigation, documentation and closure of Quality Notifications
- Responsible for monitoring and trending Quality Notification data related to components, manufacturing processes and shipped product
- Responsible for tasks associated with resolution of CAPAs and change controls
- Resolve issues related to Quality Notifications to satisfy internal customers
- Develop and revise procedures
- Provide advice, updates and documentation to Regulatory Affairs for registration of BD products in various regions
- Coordinate and lead weekly internal notification meetings
- Present notification data to Plant Manager and Leadership Team
ID/AST Senior Quality Scientist
BD Diagnostic Systems
Sparks, MD
06.2016 - 05.2019
- Responsible for coordination, investigation, documentation and closure of Quality Notifications
- Responsible for monitoring and trending Quality Notification data related to components, manufacturing processes and shipped product
- Responsible for tasks associated with resolution of CAPAs and change controls
- Resolve issues related to Quality Notifications to satisfy internal customers
- Develop and revise procedures
- Provide advice, updates and documentation to Regulatory Affairs for registration of BD products in various regions
- Coordinate and lead weekly internal notification meetings
- Present notification data to Plant Manager and Leadership Team
- Conducted investigations into questionable test results.
- Created testing protocols to be used across product lines.
- Performed visual assessment of products to evaluate conformance with quality standards.
- Reported repeated issues to supervisors and other departments, collaborating to identify root causes and rectify problems.
ID/AST Senior Quality Scientist
BD Diagnostic Systems
Sparks, MD
02.2013 - 06.2016
- Responsible for direct supervision of over 12 QMRC ID/AST (Phoenix QC) QM associates, QM Specialists I and QM Specialists II
- Responsible for applying and interpreting scientific data and ensuring good laboratory practices
- Implemented Standard Operating Procedures compliant to policies of BD Diagnostics Systems
- Maintained schedules and timelines of Quality testing
- Ensured documentation process compliance
- Provided day-to-day guidance on test methods for Quality Control testing and supplier qualifications
- Identified and recommended opportunities for continuous improvement
- Responsible for monitoring and trending laboratory data related to components, manufacturing processes and shipped product
- Ensured departmental compliance with ISO and FDA requirements through supporting internal and external audits
- Responsible for coordination and resolution of CAPAs, product notifications, change controls and customer complaints
- Resolved issues to satisfy internal customers
- Developed and revised procedures
Microbiology Supervisor
Quest Diagnostics, Inc
Baltimore, MD
12.2000 - 01.2013
- Responsible for daily operations of Microbiology Prep Lab, Virology and Urinalysis
- Manage schedules and tasks of twenty-five employees
- Manage development of employees through performance evaluations and corrective counseling
- Develop and maintain employee competency assessment program
- Prepare procedural manuals, job aids and technical bulletins
- Evaluated, validated and implemented new procedures and technologies
- Perform procedures in Microbiology Mycology, Parasitology and Virology
- Oversee training activities for over 21 MT, MLT and Lab Assistants
- Review and evaluate daily quality control and quality assurance
- Work with management and employees in process improvement strategies through lean and green belt training
- Ensure safe and orderly environment by adherence to safety policies and practices
- Participate in CAP inspections and surveys
- Plan continuing education exercises for employees
Education
Specialty of Microbiology -
University of Maryland
2004
B.A. Degree - Biology
Lincoln University
Lincoln University, PA05.1989
Skills
- Attentive and Observant
- Testing Documentation
- Finished Goods Inspection
- Verbal and Written Communication
- Regulator Submission Support
- Quality SOPs Development
- Quality Issue Identification
- Proficient in Microsoft Office
- Attention to Detail
- Proficient in SAP
Additional Information
- Title, Company Job Responsibilities 0000 to 0000, Title, Company Job Responsibilities 0000 to 0000, Title, Company Job Responsibilities 0000 to 0000, Title, Company Job Responsibilities
Timeline
Sr. Quality Systems Specialist
IDAST
05.2019 - Current
ID/AST Senior Quality Scientist
BD Diagnostic Systems
06.2016 - 05.2019
ID/AST Senior Quality Scientist
BD Diagnostic Systems
02.2013 - 06.2016
Microbiology Supervisor
Quest Diagnostics, Inc
12.2000 - 01.2013
Specialty of Microbiology -
University of Maryland
B.A. Degree - Biology
Lincoln University