QC Analyst II

Position Summary

The QC Analyst II will be responsible for analytical testing and data verification 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, Raw materials and stability programs.
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Conduct, compile, and/or review 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.
• Conducts the investigation analysis during the non-conformance.
• Works with supervisor to close the investigation.

Requirements

• Education: Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master’s degree in above areas with 6 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 & 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.
• Must be able to work extended hours or weekend hours, as may be required.
• 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.

Supervisory Responsibility

No