Shelia Crenshaw
Durham,NC
Summary
Detail-oriented Quality Control Analyst with proven skills in corrective actions, product inspections, and sampling protocols. Committed to maintaining high quality standards and improving operational efficiency.
Dynamic individual with hands-on experience in Environmental Monitoring and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.
Overview
22
22
years of professional experience
Work History
Quality Control Analyst I
Sumitomo-Pharma (ETeams Inc)
Morrisville, NC
03.2025 - Current
- Conducted routine inspections of raw materials and finished products for quality assurance compliance.
- Assisted in the development and implementation of standard operating procedures for testing processes.
- Performed data analysis to identify trends in product quality and recommend corrective actions.
- Supported cross-functional teams in investigating non-conformance issues to ensure timely resolution.
- Executed various testing procedures utilizing laboratory equipment to ensure accurate results and maintain quality standards.
- Developed comprehensive documentation, maintaining accurate records of quality control results and actions taken.
Sterile Processing Technician III
Merck-Organon
Durham, NC
10.2018 - 03.2024
- Streamlined instrument sterilization processes to enhance turnaround time and maintain compliance with safety standards.
- Trained new staff on aseptic techniques and equipment handling to ensure operational consistency and quality control.
- Conducted regular inspections of sterilization equipment, identifying maintenance needs and facilitating timely repairs.
- Collaborated with Validation/Maintenance/Clibration teams to prioritize instrument availability, improving workflow efficiency in Manufacturing Suites.
- Wrapped trays, instrument packs, and sets.
- Decontaminated process instruments to remove bacteria and other contaminants before sterilization.
- Recorded biologicals and test results.
- Maintained up-to-date knowledge on industry best practices, participating in relevant training programs and workshops.
- Propagation/Cell Culture for Growth Promotion
Bioprocess Technician II
Merck
Durham, NC
10.2012 - 10.2018
- Operated and maintained laboratory equipment to ensure optimal performance and adherence to safety protocols.
- Conducted routine inspections and preventative maintenance on systems to enhance operational efficiency.
- Collaborated with cross-functional teams to troubleshoot technical issues and implement effective solutions.
- Improved workflow processes through analysis, leading to increased productivity within the technician team.
- Led initiatives to streamline operations, resulting in reduced downtime and enhanced service delivery.
- Conducted detailed diagnostics to identify issues, leading to decrease in system downtimes.
- Performed In Process EM
- Performed daily Cell Counts
Manufacturing Production Technician
Fersenius Kabi
Raleigh, NC
09.2006 - 10.2012
- Operated and maintained production machinery, ensuring optimal performance and safety compliance.
- Conducted quality control inspections on finished products, identifying defects and initiating corrective actions.
- Collaborated with team members to streamline workflow processes, reducing downtime and enhancing efficiency.
- Assisted in training new technicians on equipment operation and safety protocols.
- Monitored inventory levels of materials, coordinating timely replenishment to prevent production delays.
- Promoted a positive work environment through effective communication, teamwork, and mutual respect among colleagues.
- Weigh out and Dispense APIs for final drug product
- Aseptic Gowning
- Perform EM per Process
Production Associate
Tyco Healthcare
Raleigh, NC
05.2004 - 09.2006
- Operated production machinery to assemble medical devices efficiently and accurately.
- Conducted quality inspections to ensure compliance with regulatory standards and specifications.
- Collaborated with team members to streamline workflows and enhance overall productivity.
- Managed inventory levels to prevent shortages and optimize material usage in production processes.
- Aseptic Gowning
- Assisted in maintaining a clean and organized work environment to support safety standards and operational flow.
- Organized work to meet demanding production goals.
- Participated in training sessions to enhance skills and knowledge.
- Inspected final products to assess compliance with quality standards and established tolerances.
Education
Bio Works Certification - Pharmaceutical Manufacturing FDA Regulated
VGCC
Louisburg05-2004
GED -
VGCC
Oxford, NC05-1996
Skills
- Corrective actions
- Quality management systems
- Product Inspections
- Sampling protocols
- Customer focus
- Sampling procedures
- Materials inspections
- Inventory management
- Equipment calibration
- Safe Laboratory Practices and Procedures
Accomplishments
- Collaborated with team of Sharholders in the development of Rethymic.
- Achieved Lab Results through effectively helping with Analytical and Miroorganism testing.
Timeline
Quality Control Analyst I
Sumitomo-Pharma (ETeams Inc)
03.2025 - Current
Sterile Processing Technician III
Merck-Organon
10.2018 - 03.2024
Bioprocess Technician II
Merck
10.2012 - 10.2018
Manufacturing Production Technician
Fersenius Kabi
09.2006 - 10.2012
Production Associate
Tyco Healthcare
05.2004 - 09.2006
Bio Works Certification - Pharmaceutical Manufacturing FDA Regulated
VGCC
GED -
VGCC