What are the responsibilities and job description for the Senior QC Laboratory Specialist position at US Tech Solutions?
Job Overview
We are seeking a highly skilled and motivated Regulatory Compliance Analyst to join our laboratory operations team. This role is responsible for ensuring compliance with regulatory requirements, including cGMPs and CF Rs, and maintaining accurate laboratory documentation.
Key Responsibilities:
- Perform routine analytical testing of drug substance and drug product, including sampling, 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
