Sr. QC Analyst

Sr. QC Analyst

We are looking for energetic and talented individuals to join our Quality Control team. You will be working to support the daily operations of the Quality Control group, while supporting the development of new processes which maximize our technology and enhance our internal and collaborative product development initiatives in a fast-paced environment.

Responsibilities:

• Support sampling and testing of incoming raw materials.
• Perform raw material ID method verification activities.
• Perform testing of analytical assays including HPLC, CE, icIEF, ELISA, Electrophoresis, UV spectroscopic based methods, and compendial methods required for the release and stability testing of, raw material, in-process, and final products.
• Perform data review and analysis.
• Support method transfer and validation activities.
• Support qualification protocol and report generation.
• Assist in generation/revision of QC Standard Operating Procedures.
• Support housekeeping and maintenance activities.
• Support stability studies.
• Interact and collaborate with Analytical Development, Manufacturing, and QA as needed.

Qualifications:

• BS in chemistry, biochemistry, bioanalytical chemistry or scientific related field with a minimum of 5 years of industry related experience or MS degree in the same fields as above with 3-5 years of industry experience.
• Experience in the testing of raw materials.
• Working knowledge of HPLC, Electrophoresis, ELISA, UV spectroscopic methods, and compendial methods.
• Experience in a GMP Quality Control working environment is highly desired.
• Experience in raw material ID testing using TruScan RM analyzer is a plus.
• Excellent interpersonal, organizational, written and oral communication skills.
• Familiar with cGMP applicable to pharmaceutical settings and with method verification/validation concepts.
• Positive team oriented can-do-attitude.
• Ability to operate in a fast-paced laboratory environment and adapt to changing assignments.