QC Analyst II
About The Position
The Quality Control Analyst II performs analytical testing and data verification for late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories. The role also contributes to continuous improvement initiatives intended to increase the efficiency and effectiveness of Kashiv’s Quality Systems. The position requires a strong background in protein chemistry to perform and troubleshoot analytical techniques, including HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays. The analyst collaborates across departments to resolve projects and laboratory investigations promptly and to advance process improvements.
Requirements
- Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field and a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory; alternatively, a master’s degree in one of these areas and 3 years of relevant experience, or a PhD in one of these areas and a minimum of 2 years of relevant experience.
- Strong background in protein chemistry and ability to troubleshoot analytical results.
- Demonstrated success working with HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
- Demonstrated success writing, revising, and complying with SOPs, protocols/reports, and QC methods.
- Ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements.
Nice To Haves
- Previous experience in a cGMP laboratory.
- Previous experience supporting regulatory inspections, such as PAI.
- Familiarity with preparing regulatory dossiers and data packages for interactions between Kashiv and regulatory agencies.
Responsibilities
- Perform analytical testing to support product in-process, release, and stability programs.
- Apply knowledge of cGMP, Quality Systems, and ICH and regulatory guidance.
- Conduct, compile, and/or review Out of Specification laboratory investigations, deviations, and corrective and preventative action plans.
- Work with cross-functional teams to advance projects and maintain equipment.
- Author documents and reports.
- Train other analysts to perform laboratory procedures and assays.
- Participate in internal assessments and audits as required.
- Perform other functions as required or assigned.
- Comply with all company policies and standards.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award.
- Long-term incentive award, such as restricted stock units.
- Comprehensive, flexible benefits program for eligible positions.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
