Michelle Dier
Lexington,KY
Summary
Dedicated and detail-oriented Quality Control Chemist with 7 years of experience in ensuring product quality and compliance with industry standards through use of analytical techniques and instrumentation coupled with strong technical writing and team collaboration skills. Seeking to grow in knowledge of technical and regulatory writing utilized in analytical and medical laboratories and apply current experience and skills to an organization committed to maintaining the highest standards of quality.
Overview
7
7
years of professional experience
Work History
Quality Control Analyst
Catalent Pharma Solutions
08.2021 - Current
- Improved overall production efficiency by identifying and resolving quality control issues.
- Conducted quality control tests and analyses on stability and finished product oral dosage units.
- Utilized analytical instruments, such as HPLC, UPLC, NIR, and GC coupled with UV, PDA, RI and FID to analyze product quality and purity
- Performed analytical testing such as Assay, Identification, Related Substances/Impurities, and Content Uniformity
- Perform testing such as Dissolution utilizing Agilent, Varian, and Distek systems, Loss on Drying, Disintegration, and Water Content using Karl Fischer titration
- Maintained accurate records of all analyses and investigations performed and complied with GMP company standard operating procedures and assisted with writing and reviewing technical documents
Quality Control Chemist II
Viatris (Formerly Mylan Pharmaceuticals)
09.2018 - 07.2021
- Conducted routine quality control testing on stability and finished products, including Assay, Dissolution, Related Compounds, and Content Uniformity
- Performed analytical tests and documented results according to company standard operating procedures and GMP guidelines
- Performed analyses utilizing HPLC and UPLC coupled with UV, PDA, and RI detectors
- Conducted cleaning validation protocols and methods
- Performed detailed quality control reviews of laboratory procedures and data for accuracy and compliance with standard operating procedures
Quality Control Chemist I
Kelly Scientific (Contractor)
02.2018 - 09.2018
- Assisted in chemical testing and analysis, gaining hands-on experience with various laboratory techniques
- Prepared chemical solutions, samples, and reagents for analytical testing
- Performed routine cleanliness inspection of laboratory workspace and equipment
- Contributed to the development of laboratory reports and documentation
Education
Bachelor of Science - Forensic Science
Eastern Kentucky University
Richmond, KY12-2016
Associate of Science -
Bluegrass Community And Technical College
Lexington, KY05-2013
Skills
- Instrumentation (HPLC, UPLC, GC, Dissolution, Karl Fischer)
- Data Analysis and Interpretation
- Wet Chemistry Techniques
- Laboratory Equipment Preventative Maintenance
- Communication and Team Collaboration
- Documentation (ALCOA)
- Technical Writing
- Computer Proficiency (MS Office, LIMS, Empower, TrackWise)
Timeline
Quality Control Analyst
Catalent Pharma Solutions
08.2021 - Current
Quality Control Chemist II
Viatris (Formerly Mylan Pharmaceuticals)
09.2018 - 07.2021
Quality Control Chemist I
Kelly Scientific (Contractor)
02.2018 - 09.2018
Bachelor of Science - Forensic Science
Eastern Kentucky University
Associate of Science -
Bluegrass Community And Technical College
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