Michelle McCormick
Batesburg
Summary
Focused Quality Specialist that delivers consistent and professional work for every assignment. Offers 6 + years in the pharmaceutical industry environment with top-notch dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
7
7
years of professional experience
Work History
Quality Specialist II
Actalent/Gilead Sciences
01.2023 - Current
- Reviewed production processes and identified potential quality issues.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Conducted data review and followed standard practices to find solutions.
- Completed independent data review of forms and batch records.
- Calculated batch records for final batch weight, needed volume, simple metric conversions and raw materials measured.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).
- Interfaces with contract manufacturers to address documentation and compliance issues.
- Approve and review CoA's in Lims.
- Write and approve minor deviations in TrackWise.
- Worked with CMO's nationally and internationally.
- Other applications/Apps used Veeva Vault, Grasp Crystal, SAP ERP, SharePoint, Box, Microsoft 365 and Adobe Acrobat Pro.
Quality Assurance/Batch Record Review
Nephron Pharmaceutical
01.2018 - 12.2022
- Reviewed records for completeness, accuracy and compliance with regulations
- Processed requests for information and released information to persons or agencies according to regulations
- Maintained continuity of work operations with documentation and communication of actions, irregularities and continuing needs
- Identified incomplete records and independently pursued missing information
- Review batch records for cGMP compliance, SOP deviations and completeness
- Making sure all guidelines and standards have been met for the for the FDA and DEA for compliance
- Identified issues and implemented prompt and successful solutions to eliminate backlog and maximize workflows
- Collaborated positively with peers and other staff members to maintain friendly, supportive and cooperative work atmosphere
- Verified facts, dates and statistics through our Standing Operating Procedures
- Working with paper records and Electronic Batch Records (EBR) for all pharmaceutical products within our company
- Review CMO batch records for Covid Testing for release
- Verifies all testing information and results for Microbiology and Chemistry are in compliance
Image Process Supervisor
WSP/Parson Brickerhoff
08.2017 - 12.2018
- Elevated team performance against objectives by helping train new team members
- Improved team performance by providing direction and hands-on support
- Strengthened team performance with continuous training strategies
- Tracked employee performance to determine areas of strength and improvement
- Focused employees on important tasks and prioritized work actions to accomplish daily goals
- Ensure smooth operations by assisting the manager with Image Processing duties
- Continuously setting objectives, assessing progress and provide on-going coaching and feedback
Education
Master's - Business Administration
Grantham University
Kansas City, MO10.2019
Batchelor's - Health Systems Management
Grantham University
Kansas City, MO07.2016
Skills
- Strong communication
- High rate of accuracy
- Highly motivated
- Multi-tasking and work prioritizatio
- Reliability
- Computer Proficiency
- Documentation skills
- Time management abilities
- Regulatory Compliance
- Communication Skills
- Batch Record Review
- Detailed documentation review
- Quality review
Timeline
Quality Specialist II
Actalent/Gilead Sciences
01.2023 - Current
Quality Assurance/Batch Record Review
Nephron Pharmaceutical
01.2018 - 12.2022
Image Process Supervisor
WSP/Parson Brickerhoff
08.2017 - 12.2018
Master's - Business Administration
Grantham University
Batchelor's - Health Systems Management
Grantham University
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