What are the responsibilities and job description for the Quality Assurance Specialist position at ICON Consultants, LP?
Responsibilities
- Perform routine in-process and release QC testing of cell products.
- Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting.
- Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
- Track and test products according to stability protocols.
- Work with internal and external resources to maintain lab in an optimal state.
- Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
- Monitor the GMP systems currently in place to ensure compliance with documented policies. Perform other lab duties as required.
Qualifications
Bachelor or Masters Degree
5 Quality Control
GMP, SOPs, and QC Process
Experience in biotech and/or pharmaceutical
