Quality Control Scientist I

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Responsibilities

Role Summary

Perform testing and decide on the acceptability of the in-process, process validation samples, finished products, stability samples, raw materials, CV samples and developmental samples in a regulated laboratory environment. Analyze and interpret results in a written and oral format. Perform data review and manage testing schedules and stability pulls.

Essential Duties And Responsibilities

• Notify management promptly of any laboratory-related or other discrepancies .
• Ev aluates test results and decide the acceptability of the samples based on the test results.
• Review QC data and manage the QC team’s testing and stability pulls.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment
• Conduct Laboratory investigations and initiate Quality Events, CAPA and Change Controls as needed
• Analyze and interpret results in written and oral format.
• Maintain the laboratories with good housekeeping practi ces and in compliance with cGMP.
• Ensure notebooks are reviewed promptly, in accordance with SOPs.
• Perform routine tests of finished product and stability samples , raw materials and CV samples, including, assays, chromatographic purity, content uniformity using UV , GC and HPLC, particle size distribution using different techniques including, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
• Training of new analysts .
• Monitor the team’s training compliance in the company procedures.

Education & Experience

• May lead and direct the work of others.
• Excellent communication skills, including the ability to speak, listen and gain clarification, respond well to questions, and write clearly and informatively.
• Bachelor’s degree in Chemistry or related scientific field and 3-5 years related exper ience in the pharmaceutical industry OR Master’s degree in Chemistry or related scientific field and 2 year related exper ience in the pharmaceutical industry .
• Aid in the writing of laboratory practices and procedures.
• Ability to deal with problems involving several concrete variables in standardized situations.
• Working knowledge of instrumentation software used in the laboratories.
• Assist in the validation of Quality Control methods.
• Familiarity with analytical methodology, laboratory practices, wet-chemistry, HPLC/UPLC, UV-Vis, etc., preferred.
• Knowledge of Excel and MS-office, Powerpint
• A wide degree of creativity and latitude is expected.
• Ability to carry out necessary computations and to draw and interpret graphs.
• To perform this job successfully, an individual should have:
• Helps assist in the generation of laboratory practices and modifications of standard operating procedures.

P Hysical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking , and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting to 15 pounds occasionally. Generally work is performed in a laboratory environment.

Qualifications

COVID19 Vaccination Requirements:

If you are hired, Lupin will require you to prove that you are fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from becoming vaccinated. As an employee, you will be required to follow Lupin policies related to any additional or future COVID-19 vaccination or booster shot requirements.