QC Analyst III -Chromatography

Amneal

2d•$93,000 - $123,000•Onsite

About The Position

The Quality Control Analyst performs analytical testing and data verification to support 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, 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 and typing work, and plant auditing. Brief or minimal exposure to hazardous chemicals may occur, and personal protective equipment may be required. Safety alertness is necessary when working around hazardous equipment and conditions. The role may require flexible hours and the ability to work under pressure and meet deadlines. There is no supervisory responsibility. The stated salary range is $93,000–$123,000 per year. The company also offers a short-term incentive opportunity, such as a bonus or performance-based award, and a long-term incentive award, such as restricted stock units, within the first 12 months. Eligible employees may choose from a comprehensive benefits program that includes health and insurance benefits, a significant 401(k) matching contribution, and well-being programs.

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 and experience troubleshooting analytical results.
Demonstrated success writing, revising, and complying with SOPs, policies, and QC methods.
In-depth understanding and technical knowledge of analytical methods including UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA in a QC laboratory environment.
Familiarity with basic and some complex laboratory equipment and instrumentation.
Strong written and verbal communication skills.
Detail-oriented, with the ability to manage time effectively and complete assignments.
Excellent computer skills in Microsoft Office applications.
Able to read, write, and understand English.
Able to work under pressure and meet deadlines.

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 preventative 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.