Quality Assurance Specialist

Lupin is a fast-growing, innovative team with manufacturing, Research and Development, and commercial divisions focused on generic and branded U.S. business. Our first U.S. R&D facility is in Coral Springs, Florida, specializing in orally inhaled and nasal drug products, while our Somerset, New Jersey site houses commercial manufacturing and additional R&D teams.

About the role

The position manages the lifecycle of master documents, ensuring compliance with regulations, company procedures, and industry standards. It also oversees the control of controlled documents, including issuance, archival, and retrieval.

Responsibilities

• Participate in the design and development of Lupin’s Quality Systems and support continuous improvement.
• Issue GMP documents such as logbooks, notebooks, and batch records.
• Liaise with SMEs and stakeholders to ensure documents are accurate, complete, and delivered on time.
• Collaborate with functional departments to identify procedural controls for compliance improvement.
• Support internal and third-party audits at the LIR site.
• Partner with Operations, Product Development, Quality Control, Engineering and Facilities, Manufacturing, and Supply Chain to ensure site compliance.
• Support the employee training program.
• Manage QA retain samples and archival of GMP documents.
• Provide support in documenting investigations and Root Cause Analysis.
• Perform other QA duties as assigned.

Requirements

• Bachelor’s Degree (B.S.) in Chemistry, Biology, Microbiology, Pharmacy, or a related field (preferred).
• Minimum of 1-3 years’ experience in an FDA-regulated environment within Quality Assurance, with document control experience.
• Strong understanding of cGMP regulations as they apply to Drugs and Medical Devices.
• Ability to enforce adherence to internal quality policies, procedures, and cGMP.
• Ability to work with diverse departments and individuals.
• Team-oriented with excellent interpersonal skills.
• Ability to clearly communicate regulatory requirements.
• Strong oral and written English skills.

Physical Requirements

• Frequent standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing.
• Occasional bending, kneeling, crouching, stooping, and crawling.
• May require lifting up to 15 pounds occasionally.
• Work is primarily performed in an office environment.

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility