QC Analyst III - Phys/chem

Amneal

2d • Onsite

About The Position

The Quality Control Analyst performs analytical testing and data verification in cGMP-compliant laboratories, supporting late-stage clinical and commercial small-molecule and biosimilar products. The role requires a strong background in protein chemistry and the ability 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 support process improvements.

The position supports in-process, release, and stability testing; conducts, compiles, or reviews out-of-specification investigations, deviations, and corrective and preventive action plans; and works with cross-functional teams on projects, equipment maintenance, and document and report authoring. The role also requires compliance with company policies and standards. This is an onsite position, five days per week, with stated hours of 9:00 AM to 5:30 PM EST and flexibility to work additional hours as needed. The work environment includes manufacturing clean rooms and possible brief or minimal exposure to hazardous chemicals, requiring personal protective equipment.

Requirements

• 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, with 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/regulatory guidance.
• Strong written and verbal communication skills.
• Detail-oriented, with the ability to manage time effectively and complete assignments.
• Must be able to read, write, and understand English.
• Ability to work under pressure and meet deadlines.

Nice To Haves

• In-depth understanding and technical knowledge of UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA in a QC laboratory environment.
• Familiarity with basic and some complex laboratory equipment and instrumentation.
• Excellent computer skills in Microsoft Office applications.
• Ability to work flexible hours as needed.

Responsibilities

• Perform analytical testing supporting product in-process, release, and stability programs.
• Verify analytical data supporting late-stage clinical and commercial small-molecule and biosimilar products.
• 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, resolve laboratory investigations, and support process improvements.
• Maintain equipment and author documents and reports.
• Comply with company policies and standards.
• Perform other functions as required or assigned.

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.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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