Quality Control Analyst IV - Reviewer

Amneal • Piscataway, NJ

7d • $120,000 - $145,000

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 to perform and troubleshoot analytical methods, as well as the ability to collaborate across departments to resolve projects and laboratory investigations promptly and support process improvements.

The position supports product in-process, release, and stability testing. It also conducts, compiles, and/or reviews out-of-specification laboratory investigations, deviations, and corrective and preventive action plans. The analyst works with cross-functional teams on projects, equipment maintenance, and document and report authoring, and performs other assigned functions while complying with company policies and standards.

The work environment may include manufacturing clean rooms, plant auditing, and brief or minimal exposure to hazardous chemicals requiring personal protective equipment. The role requires safety alertness around hazardous equipment and conditions, the ability to read, write, and understand English, and the ability to work flexibly as needed, under pressure, and to deadlines.

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 master’s degree in one of these areas and 8 years of experience, or a PhD 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.
• Strong knowledge of cGMP, Quality Systems, and ICH and regulatory guidance.
• Ability to read, write, and understand English.
• Ability to work flexible hours as needed and work under pressure to meet deadlines.
• Safety alertness when working around hazardous equipment and conditions.

Nice To Haves

• Demonstrated success working 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.
• Work with cross-functional teams to advance projects and maintain equipment.
• Author documents and reports.
• 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, 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