QC Analyst III

Position Summary

The QC Analyst III will be responsible for analytical testing and data verification/review supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.

Essential Duties & Responsibilities

• Analytical testing to support product in-process, release, and stability programs.
• Perform the data verification/Review process as assigned.
• Participate in Method Validation activity.
• Preparation of the Protocols/Reports as assigned.
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Coverage of Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
• Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.
• Performs other functions as required or assigned
• Complies with all company policies and standards
• Preparation and routing the change control documents as required.

Position Requirements and Qualifications

• Education: Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 10 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, master’s degree in above areas with 8 years of experience in a pharmaceutical/biotech QC laboratory.
• Experience: Previous experience in a cGMP laboratory. Strong background in small molecule and protein chemistry and experience troubleshooting analytical results. Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.
• Specialized Knowledge and Skills: Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. Knowledge of and experience with Empower and/or Shimadzu software. Previous experience supporting regulatory inspections (e.g. PAI). Familiarity with preparing regulatory dossiers and data packages for interactions between Kashiv and regulatory agencies.

Work Environment & Physical Demands

• General Working Environment: Some time spent in an office doing office work (reading, writing, reviewing, and editing documents). Significant amount of time spent in the laboratory.
• Noise: No extraordinary noise levels.
• Standing/Lifting: Must be able to lift at least 25 lbs.
• Visual: No extraordinary requirements.
• Stress: High-paced demanding environment to meet ambitious project goals.
• Travel: No travel required.
• Supervisory Responsibility: No