QC Analyst II

Description

 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. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.

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
• Perform the investigation analysis during the non-conformance.
• Conduct the investigation process as a part of Quality Event and work with supervisor to close the investigation.

Requirements

 Position Requirements and Qualifications

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 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.

· Must be able to work extended hours or weekend hours, as may be required.

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, if any: No

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.