QC Analyst II

Amneal

1d

About The Position

The Quality Control Analyst II performs analytical testing and data verification in cGMP-compliant laboratories, supporting late-stage clinical and commercial biosimilar products. The role also contributes to continuous improvement initiatives to improve the efficiency and effectiveness of Kashiv’s Quality Systems. A strong background in protein chemistry is important for performing and troubleshooting analytical techniques and assays. The analyst collaborates across departments to support timely resolution of projects, laboratory investigations, and process improvements.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field and at least 5 years of experience in a pharmaceutical or biotechnology QC laboratory; alternatively, a master’s degree in one of these areas and 3 years of relevant laboratory experience, or a PhD in one of these areas and at least 2 years of relevant laboratory experience.
• Strong knowledge of cGMP, Quality Systems, and ICH and regulatory guidance.
• Strong background in protein chemistry and experience troubleshooting analytical results.
• Demonstrated success writing, revising, and complying with SOPs, protocols, reports, and QC methods.
• Demonstrated success working with HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
• Ability to collaborate across departments to resolve projects, laboratory investigations, and process improvement work.
• Must be able to lift at least 25 lbs.

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 for product in-process, release, and stability programs.
• Conduct, compile, and/or review out-of-specification laboratory investigations, deviations, and corrective and preventive action plans.
• Work with cross-functional teams to advance projects, maintain equipment, and 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 company policies and standards.
• Contribute to continuous improvement initiatives for Quality Systems.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award.
• Long-term incentive award, such as restricted stock units.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level