Quality Control Analyst IV - Reviewer

Amneal

7d

About The Position

The QC Analyst IV is responsible for analytical testing and data verification supporting late-stage clinical and commercial small-molecule and biosimilar products in cGMP-compliant laboratories. The role requires a strong background in protein chemistry and the ability to perform and troubleshoot analytical techniques, as well as collaborate across departments to resolve projects and laboratory investigations and support process improvements.

The position performs testing for in-process, release, and stability programs; works with cross-functional teams on projects and equipment; and authors, compiles, or reviews laboratory documents, reports, investigations, deviations, and corrective and preventive action plans. The role also requires compliance with company policies and standards and the ability to work flexible hours as needed.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field and at least 10 years of experience in a pharmaceutical or biotech QC laboratory; alternatively, a relevant master’s degree and 8 years of experience, or a Ph.D. and at least 6 years of experience.
• Previous experience in a cGMP laboratory.
• Strong background in small-molecule and protein chemistry and experience troubleshooting analytical results.
• Demonstrated success writing and revising SOPs and complying with SOPs, policies, and QC methods.
• Ability to read, write, and understand English.
• Ability to work flexible hours as needed and under pressure to meet deadlines.

Nice To Haves

• Experience with HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
• 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.
• Conduct, compile, and/or review out-of-specification laboratory investigations, deviations, and corrective and preventive action plans.
• Collaborate with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
• Perform other functions as required or assigned.
• Comply with company policies and standards.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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