Senior Scientist, Quality Control

RXinsider LTD.; Piscataway Township (NJ); On-site; USD 115,000 - 120,000; Full time

Job summary

Amneal is seeking a Senior Scientist, Quality Control to perform comprehensive testing of raw materials, in-process, and finished products, including stability testing. You will validate methods, calibrate HPLC/GC instruments, and ensure compliance with SOPs and cGMP standards.

Responsibilities include data review, investigations, and supporting non-routine projects while maintaining strict documentation and quality control practices. This role is based in Piscataway, NJ.

Qualifications

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated) and measuring physical parameters.
• 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 troubleshoot complex analytical and instrument-related problems and report actions to management.
• Must be able to identify trends in analytical data.
• Must have 60 months of experience in the position or in a related position.

Responsibilities

• Perform testing of raw materials, in-process and finished dosage forms, and products on stability.
• Calibrate HPLC, GC, and other equipment; perform validation testing as assigned.
• Document steps and report results in specification documents.
• Assist with method transfer activities and investigations.
• Provide feedback on analytical systems and procedures for continuous improvement.

Skills

Analytical chemistry

cGMP knowledge

Data trend analysis

Troubleshooting

Documentation

Education

Bachelor's degree in Pharmacy or Chemistry or Pharmaceutical Manufacturing

Tools

HPLC

GC

UV-Vis spectrophotometer

Infra-red spectrophotometer

Karl Fischer

Dissolution apparatus

pH meter

Job description

Job Description

Senior Scientist, Quality Control:

Responsible for performing 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. 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. 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.

Job Location: Piscataway, NJ.

Salary: $115K - $120K per annum.

Hours: 40 hrs/wk 8:30am - 5:30pm

Location: Piscataway

Qualifications

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated) 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.
• Must have at least a Bachelor’s degree in Pharmacy or Chemistry or Pharmaceutical Manufacturing.
• Must have 60 months of experience in the position or in a related position.

About Us

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.