Quality Assurance Specialist

Quality Assurance Specialist

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