Data Reviewer-Senior Scientist, Quality Control

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

401(k) matching contribution

Comprehensive health and insurance benefits

Performance-based bonus or award

Job summary

Amneal Pharmaceuticals is seeking a Scientist 3 – QC in Piscataway Township, NJ. This role involves performing testing for raw materials and pharmaceutical products, ensuring compliance with safety regulations and historical data. Candidates must hold a Bachelor's Degree in Chemistry or a related field and possess extensive experience in analytical chemistry techniques. The base salary ranges from $85,000 to $105,000 annually, complemented by various benefits. Amneal is an Equal Opportunity Employer.

Qualifications

• 5 years of experience in testing of chemicals/pharmaceutical products with a Bachelor's Degree.
• 3 years of experience in testing with a Master's Degree.
• In-depth knowledge of spectrophotometric techniques and chromatographic techniques.

Responsibilities

• Perform testing of raw materials and pharmaceutical products.
• Document and report results following SOPs and specifications.
• Assist in method transfer activities and provide feedback on procedures.

Skills

Analytical chemistry techniques

cGMP compliance

Problem-solving

Education

Bachelor’s Degree in Chemistry or related science

Master’s Degree in Chemistry or related science

Tools

HPLC

UV-Vis spectrophotometer

Karl Fischer

Laser diffraction

TLC

pH meter

Analytical balances

Job description

Description

The Scientist 3 – QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.

Essential Functions

• Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including stability products, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out‑of‑specification situations. Assure compliance with state and federal regulations.
• Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required.
• Use sonic sifter, laser diffraction, Karl Fischer, UV‑Vis spectrophotometer, infrared spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, dissolution apparatus equipped with auto‑sampler and/or in‑line UV, pH meters, analytical balances, and Karl‑Fischer titrator.
• Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.
• Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.
• Report any abnormal findings to the Supervisor. As assigned, perform in‑depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.

Additional Responsibilities

• Assist the laboratory supervisor with handling non‑routine special projects requiring activities such as out‑of‑specification investigations and out‑of‑alert limit investigations in the laboratory.
• Ensure that expired chemicals and reference standards are removed from laboratory area.
• Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.
• Assist with hands‑on training of newly hired Technicians or Scientists 1 and 2 levels.

Qualifications

• Education: Bachelor’s Degree (BA/BS) in Chemistry or related science discipline – Required; Master’s Degree (MS/MA) in Chemistry or related science discipline – Preferred.
• Experience: 5 years or more with a Bachelor’s Degree – testing of chemicals/pharmaceutical products; 3 years or more with a Master’s Degree – testing of chemicals/pharmaceutical products.
• Specialized Knowledge: In-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques). Ability to follow compendial (USP/EP/BP/JP) procedures for analysis; understand and apply cGMP requirements applicable to quality control laboratory; advanced technical skills to troubleshoot and resolve complex analytical and instrument‑related problems effectively and in a timely manner and report actions to the laboratory management timely; ability to identify trends in analytical data.

Compensation and Benefits

The base salary for this position ranges from $85,000 to $105,000 per year. In addition, Amneal offers a short‑term incentive opportunity, such as a bonus or performance‑based award, with this position within the first 12 months. Amneal provides a comprehensive, flexible and competitive benefits program, including above‑market health and insurance benefits and a 401(k) matching contribution.

Equal Opportunity Employer

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.