Lupin Pharmaceuticals
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Quality Assurance Associate
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Lupin Pharmaceuticals . Lupin is comprised of a fast growing, innovative and robust team spanning manufacturing, research and development, and commercial divisions. Together these entities constitute the generic and branded U.S. business. Lupin has a significant generic pipeline and focuses on women's health. Our first U.S. research and development facility in Coral Springs, Florida focuses on generic and branded orally inhaled and nasal drug products, while Somerset, New Jersey hosts one of fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Responsibilities
Participate in the design and development of Lupin's Quality Systems and provide support of continuous improvement and management of Quality Systems. Issue GMP documents such as logbooks, notebooks, batch records, etc. Release cleanrooms after cleaning activities. Inspect and release GMP areas prior to manufacturing activities. Inspect incoming materials, in‑process and finished products. Support review of cGMP documentation, including specifications, standard operating procedures, test methods and batch records. Support internal and third‑party audits at LIR site. Facilitate quality‑related training and mentoring as required. Partner 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. Manage QA retain samples and archive GMP documents. Support documentation of investigations and Root Cause Analysis. Perform other QA duties as assigned. Qualifications
A Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field is preferred. A minimum of 1‑3 years of experience in an FDA‑regulated or Pharmaceutical/Medical Device manufacturing environment. A thorough knowledge of cGMP regulations as they apply to Drugs and Medical Devices is required. Relevant experience with laboratory and manufacturing functions along with GMP quality assurance functions 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; able to express regulatory requirements clearly and understandably. Must possess good oral and written skills in English. Availability to work the second shift. 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. Bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Work is generally performed in an office environment. Equal Employment Opportunity
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. Recruitment Notice
Lupin USA, and its affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid if a candidate is hired by Lupin as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
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Quality Assurance Associate
role at
Lupin Pharmaceuticals . Lupin is comprised of a fast growing, innovative and robust team spanning manufacturing, research and development, and commercial divisions. Together these entities constitute the generic and branded U.S. business. Lupin has a significant generic pipeline and focuses on women's health. Our first U.S. research and development facility in Coral Springs, Florida focuses on generic and branded orally inhaled and nasal drug products, while Somerset, New Jersey hosts one of fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Responsibilities
Participate in the design and development of Lupin's Quality Systems and provide support of continuous improvement and management of Quality Systems. Issue GMP documents such as logbooks, notebooks, batch records, etc. Release cleanrooms after cleaning activities. Inspect and release GMP areas prior to manufacturing activities. Inspect incoming materials, in‑process and finished products. Support review of cGMP documentation, including specifications, standard operating procedures, test methods and batch records. Support internal and third‑party audits at LIR site. Facilitate quality‑related training and mentoring as required. Partner 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. Manage QA retain samples and archive GMP documents. Support documentation of investigations and Root Cause Analysis. Perform other QA duties as assigned. Qualifications
A Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field is preferred. A minimum of 1‑3 years of experience in an FDA‑regulated or Pharmaceutical/Medical Device manufacturing environment. A thorough knowledge of cGMP regulations as they apply to Drugs and Medical Devices is required. Relevant experience with laboratory and manufacturing functions along with GMP quality assurance functions 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; able to express regulatory requirements clearly and understandably. Must possess good oral and written skills in English. Availability to work the second shift. 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. Bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Work is generally performed in an office environment. Equal Employment Opportunity
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. Recruitment Notice
Lupin USA, and its affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid if a candidate is hired by Lupin as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
#J-18808-Ljbffr