Quality Assurance Associate

Quality Assurance Associate

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.

Responsibilities

Role Summary

Quality Assurance Associate independently performs tasks with minimal supervision ensuring compliance with LIRC Quality Assurance programs and procedures, and all applicable predicate rules. Assists in the maintenance of Quality Systems and develops new controls and procedures that are appropriate and effective as part of continuous Quality Improvement activities at the site. Ensures that Laboratory and Manufacturing functions are operating in full compliance with the Current Good Manufacturing Practices (cGMPs), regulatory requirements, company procedures and continuous improvement.

This position will require flexibility to work between 1st and 2nd shift - but will lean heavier to 2nd Shift. 3:00 p.m. - 11:00 p.m.

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.
• Release of cleanrooms after cleaning activities.
• Inspection and release of GMP area prior to manufacturing activities.
• Inspection of incoming materials, in process and finished products.
• Provide support in the review of cGMP documentation, including, but not limited to specifications, standard operating procedures/ test methods, and batch records.
• Support internal and to 3rd party audits at LIR site.
• Facilitate quality-related training and mentoring, where required.
• 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.

Qualifications

Education & 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 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. Must have the ability to express regulatory requirements clearly and understandably.
• Must possess good oral and written skills in the English language.
• Availability to work in second shift.

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.