What are the responsibilities and job description for the Regulatory Compliance Analyst - Lab Operations position at US Tech Solutions?
About the Position
This Pharmaceutical Quality Assurance Coordinator role is a crucial part of our laboratory operations team. As a key player in ensuring the highest quality standards, you will be responsible for performing routine analytical testing of drug substance and drug product, maintaining equipment, and adhering to strict cGMP guidelines.
Key Responsibilities:
- Perform routine laboratory procedures, including sample collection, handling, and testing equipment support
- Document and enter data into computerized systems while maintaining accuracy and attention to detail
- Maintain and operate specialized equipment, as well as initiate and implement changes in controlled documents
- Comply with safety guidelines and regulations, including training records, laboratory documentation, written procedures, building monitoring systems, and laboratory notebooks
Requirements
- Master's degree OR Bachelor's degree and 1-2 years of Quality or Analytical Laboratory experience OR Associate's degree and 3-5 years of Quality or Analytical Laboratory experience OR High school diploma/GED and ?5 years of Quality or Analytical Laboratory experience
- Experience with HPLC/UPLC, general chemistry, capillary electrophoresis, and GMP analytical laboratories
- Self-motivated, strong organizational skills, and ability to manage multiple tasks at one time with minimal supervision
- Strong communication skills (both written and oral), facilitation, and presentation skills
- Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories
- Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
