QC Analyst III - Phys/chem

Amneal • Piscataway, NJ

3d • $93,000 - $123,000 • Onsite

About The Position

The Quality Control Analyst performs 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 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 support process improvements.

The position is onsite five days a week, from 9:00 AM to 5:30 PM EST. The work environment includes manufacturing clean rooms, desk work, typing, and plant auditing. Brief or minimal exposure to hazardous chemicals may occur and require personal protective equipment. The role also involves working around hazardous equipment and conditions, and may require flexible hours and the ability to work under pressure and meet deadlines. There is no supervisory responsibility.

Requirements

• Four-year bachelor's degree in biotechnology, biochemistry, chemistry, or a related field.
• Five or more years of experience in a cGMP biologics/biosimilars manufacturing laboratory environment.
• Working knowledge of cGMP regulations, including 21 CFR 210/211/820.
• Strong background in small molecule and protein chemistry and experience troubleshooting analytical results.
• Demonstrated success writing and revising SOPs, policies, and QC methods, and complying with them.
• Ability to read, write, and understand English.
• Ability to work flexible hours as needed, work under pressure, and meet deadlines.

Nice To Haves

• In-depth understanding and technical knowledge of QC laboratory analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA.
• Familiarity with basic and some complex laboratory equipment and instrumentation.
• Strong written and verbal communication skills.
• Detail-oriented.
• Ability to manage time effectively to complete assignments.
• Excellent computer skills in Microsoft Office applications.

Responsibilities

• Perform analytical testing supporting 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 preventive action plans.
• Work with cross-functional teams to advance projects, maintain equipment, and 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.
• Long-term incentive award, such as restricted stock units, within the first 12 months.
• Comprehensive, flexible, and competitive benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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