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QA Specialist, Documentation

Lupin Pharmaceuticals Inc.
Somerset, New Jersey, US
Closing date
Jan 15, 2022

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Academic / Research, Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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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 womens 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.

The position is responsible for lifecycle management of analytical procedures by ensuring that the laboratory test methods, specifications, and other procedures comply with USP, Regulatory requirements, commitments, and other in-house standards. In addition, the person is responsible for drafting protocols, reports, and other GMP documents. The position will consult with technical personnel on testing requirements and specifications, as well as consult relevant SOPs to assure complianceDevelop and implement policies and procedures applicable to master documents consistent with FDA regulations and Corporate requirements Preparation of specifications, justification of specifications, analytical methods, method validation protocols, summaries, reports, and laboratory-related SOPs.Organizing and maintenance approved, archived, and draft documents like laboratory SOPs, analytical specifications, methods, technical reports, justifications, memos, document history, etc.Work with external partners (Vendors, Contract Laboratories) to determine, harmonize, and communicate testing requirements for products and materialsMonitor Pharmacopeial Forum and Pharmacopeia periodically for an announcement of upcoming changes and work closely with Quality Control for the planned implementationInitiation and tracking of change controls, deviations, CAPA, deliverable tasks for change controls, etc.Liaise with laboratory staff and project stakeholders to ensure documents are accurate and delivered within timelinesCollaborate with functional departments to identify additional procedural controls for overall improvement of compliance.Collaborate with SMEs to organize Classroom or On the Job training sessions for strengthening organizational technical/functional expertise Write, and review, deviations related to laboratory testing. Extend support from Laboratory for cross-functional investigations. Conduct investigations related to GMP in other areas when necessary.Conduct experiments on occasion to develop and/or demonstrate the robustness of methodsDevelop and monitor department metrics and reports. Report progress to site leadership periodically. Any other duties as assigned by Functional Manager

Bachelors Degree in a Scientific Field or 4+ years of experience in a pharmaceuticals environment, with strong experience in documentation.5+ years of experience in a Pharmaceutical laboratory environment in oral dosage forms. Experience with other dosage forms is a plusStrong working knowledge of analytical techniques such as Chromatography, Dissolution, and other instrument and wet chemistry testing.Excellent understanding of USP General Chapters, General Notices and Monographs.Good Understanding of the current regulatory requirements for analytical testing documentation (ICH, FDA) and cGMP laboratory systems for commercial pharmaceutical applicationsExcellent technical writing skills and command of the English languageMust have experience working with Electronic Quality Management Systems such as TrackWise, MasterControl, Veeva, ETQ etc.Ability to work with computers and software applications like Microsoft Word and ExcelCOVID19 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 requirementsPhysical RequirementsThe physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. This position may require lifting up to 15 pounds occasionally. Generally work is performed in a laboratory environment.
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