Quality Control Analyst

Scope of Function: Work within the Analytical Chemistry area 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.

Specific Duties:

• Understand and perform a wide range of analytical techniques including pH, protein concentration, electrophoresis, HPLC, ELISA and visual inspections.
• Interpret experimental data to statistically summarize results and key findings.
• Create or revise departmental SOPs.
• Create, execute and compile qualification and validation protocols/reports related to Analytical
• Investigate/troubleshoot assay problems.
• Write deviations, investigations and OOS reports as necessary
• Other duties as necessary

Education, Experience and Skills:

BS in a scientific discipline and at least two to three years work experience in GLP/GMP FDA regulated environment.