QC Analyst III
Scope of Function:
Work within the Bio-analytical Chemistry group to provide analytical support, test results and qualification of analytical methods and stability studies for clients in pre clinical and clinical development. Work with process development and manufacturing groups by providing QC support to assess the purity, potency, strength and stability of in process and final vialed product. Develop and write SOP’s, qualification protocols, investigations, deviations and reports. Summarizes and interpret analytical data and present results in team meetings.
and perform a wide range of analytical techniques including pH, protein
concentration, electrophoresis, HPLC, ELISA and visual inspections.
experimental data to statistically summarize results and key findings.
or revise departmental SOPs.
manufacturing meetings and other meetings as required.
qualification and validation protocols.
execute and compile qualification and validation protocols/reports related
deviations, investigations and OOS reports as necessary.
duties as necessary
Education, Experience and Skills Required:
BS in a scientific discipline.
Must have at least five years work experience in GLP/GMP FDA regulated environment.
contractors for certification or calibration of equipment and testing
manufacturing, Process Development /Quality Assurance department.
as needed for audits or technical information.
Goodwin Biotech - 9 months ago