Data Reviewer-Senior Scientist, Quality Control

RXinsider LTD.; Piscataway Township (NJ); On-site; USD 85,000 - 105,000; Full time

Job summary

Amneal is seeking a Scientist 3 - QC to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, including products on stability, and to report results following SOPs and applicable cGMP guidelines.

You will participate in method transfer activities, assist with investigations, calibrate analytical instruments (HPLC, GC, UV, dissolution), and contribute to continuous improvement of analytical procedures and compliance.

Qualifications

• Bachelor's degree in Chemistry or related science; required
• Master's degree in Chemistry or related science; preferred
• 5+ years in BA/BS-level testing of chemicals/pharmaceutical products
• 3+ years in Master's level testing of chemicals/pharmaceutical products
• In-depth knowledge of analytical chemistry techniques (spectrophotometric, dissolution, chromatographic) and related instruments
• Ability to follow compendial procedures (USP/EP/BP/JP) and apply cGMP in QC lab

Responsibilities

• Perform physical and chemical analysis of raw materials, in-process and finished products per SOPs and specifications
• Participate in process validation and cleaning validation/verification testing
• Calibrate and operate HPLC, GC, and dissolution equipment; maintain instrument routine performance
• Document analyses, report results, and investigate data anomalies
• Review laboratory data for completeness and compliance with policies
• Assist with non-routine projects and instrument-related problem solving
• Provide hands-on training to Technicians or Scientists levels 1 and 2

Skills

Analytical chemistry

Data analysis

Troubleshooting

Instrument calibration

Education

Bachelor's degree in Chemistry or related science

Master's degree preferred

Tools

HPLC

GC

UV-Vis

Spectrophotometry

Dissolution testing

FTIR

Job description

Job 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 products on stability, 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 situation. 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, Infra-red 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

• Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
• Master Degree (MS/MA) Chemistry or related science discipline - Preferred

Experience

• 5 years or more in Bachelors Degree (BA/BS) -Testing of chemicals/pharmaceutical products
• 3 years or more in Masters Degree (BA/BS) -Testing of chemicals/pharmaceutical products

Specialized Knowledge

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) 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).
• Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Must have ability to apply 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 in a timely manner.
• Must be able to identify trends in analytical data.

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 ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

About Us

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.