What are the responsibilities and job description for the QC Analytical Specialist position at BioPhase?
Job Summary
The QC Analytical Specialist will serve as SME and advise contract testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties will include data review and troubleshooting of analytical test methods.
Responsibilities
- Author, review and revise documentation (SOPs, test methods, analytical method development, method validation, method transfer protocols/ reports, product specifications)
- Review QC stability and lot release data (data integrity check) and CoAs issued by contract testing laboratories and create batch release certificate of analysis
- Author and review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable
- Author, review and revise Analytical Section of documents such as the IND, BLA for regulatory CMC submission
- Provide technical expertise to troubleshoot analytical methods
- Mange suppliers change notifications and change controls
- Collaborate with other departments (e.g. QA and Regulatory) for quality control related duties
- Attend QC-Analytical internal meetings and external meetings with contract testing laboratories
- May conduct other duties, as assigned
Experience
- Bachelor's degree with 8 OR Master's degree with 6 of years relevant experience in Analytical Chemistry or related discipline required;
- Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development required
Job Types: Full-time, Contract, Temporary
Pay: $45.00 - $49.00 per hour
Work Location: In person
Salary : $45 - $49