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Quality Assurance Specialist

Lupin
CompanyLupin
CategoryOperations & Admin
Location
Remote
EmploymentNot stated
LevelNot stated
SalaryNot stated by the employer
First seen3 Aug 2026 (the employer did not state a posting date)
Last verified9 Aug 2026
SourceThe employer's own careers page (company_site)
Applications are handled by the employer, not by us.Apply on the employer's site →
Description
Caution Notice – “Recruitment Fraud” It is hereby cautioned to the general public that in recent past, some individuals and recruitment agencies have tried to mislead the public by fictitiously claiming to be employees of Lupin Limited (and/or its group companies) or posing as authorized recruitment agencies of Lupin Limited (and/or its group companies). It has been brought to our notice that they send fake e-mails to the potential job seekers luring them with job offers and appointment letters using the details of Lupin Limited (and/or its group companies). These individuals / recruitment agencies are misguiding the job-seekers by promising them well-placed jobs with the company and asking them for a security deposit for providing return air-fare for the final round of interview. Further, they are corresponding through fake letterheads and bogus mail id’s of @lupin.com domain name. Kindly note that Lupin Limited (and/or its group companies) follows a formal recruitment process through its own HR department and does not outsource the final selection of prospective employees to any individuals or agencies. Further, Lupin Limited (and/or its group companies) does not ask for any security deposit or fees (refundable or non-refundable) at any stage of recruitment process. Please be advised that any potential job-seeker willingly corresponding with such individuals and recruitment agencies in any manner whether by e-mails or otherwise will be doing so at their own risks and consequences. Lupin Limited (and/or its group companies) strongly recommends that the potential job-seekers should not respond to such solicitations. Kindly note that Lupin Limited (and/or its group companies) will not accept any liability for any loss or damage that may be suffered or incurred directly or indirectly through correspondence with fraudulent individuals or recruitment agencies and that such communication should not be treated as an offer or representation from Lupin Limited (and/or its group companies). Should you come across any such fraudulent incident or have any information regarding solicitation for recruitment or employment with Lupin Limited (and/or its group companies), please assist us in taking appropriate action to curb such mala fide activities. You may reach us: Mr. Raoul Dsouza – [email protected] | 022 66402113 Ruchita Vartak – [email protected] | 022 66402118 About Us Products Investors About Us Products Investors Quality Assurance Specialist Date: Jul 17, 2026 Location: FL, US Company: Lupin Job Description 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 Fifteen 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. Role Summary The position is responsible for lifecycle management of master documents by ensuring that all the master documents at Lupin Coral Springs site comply with applicable regulations, company procedures, and industry standards. This position is also responsible for control of controlled documents with emphasis in the document issuance, archival and retrieval. Essential Duties AND Responsibilities • Participate in the design and development of Lupin’s Quality Systems and provide support of continuous improvement and management of Quality Systems. • Issuance of GMP documents i.e. logbooks, notebooks, batch records, etc. • Liaison with SMEs and stakeholders to ensure documents are accurate, complete, and delivered within timelines. • Collaborate with functional departments to identify additional procedural controls for overall improvement of compliance. • Support internal and to 3rd party audits at LIR site. • Partnership with other functional areas (Operations, Product Development, Quality Control, Engineering and Facilities, Manufacturing, and Supply Chain) to ensure site continuous compliance. • Support employee training program. • Management of QA retain samples and archival of GMP documents. • Provide support in the documentation of investigations and Root Cause Analysis. • Perform other QA duties as assigned. Qualification and Experience • A Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field is preferred. • A minimum of 1-3 years’ experience in an FDA-regulated environment within Quality Assurance department and experience with control of documents. • A good understanding of cGMP regulations as they apply to Drugs and Medical Devices is required. • Ability to enforce adherence to internal quality policies, procedures and cGMP. • Ability to interface and work with a diverse group of departments and individuals is required. • Must be team oriented with excellent interpersonal skills. Must have the ability to express regulatory requirements clearly and understandably. • Must possess good oral and written skills in the English language. Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law. Physical 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 up to 15 pounds occasionally. Generally work is performed in an office environment. Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility × When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. 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