Quality Assurance Jobs at Lupin Pharmaceuticals USA
Looking to build a strong career in Quality assurance jobs within the pharmaceutical industry? This Quality Assurance Associate position at Lupin Pharmaceuticals in Coral Springs, Florida, offers an excellent opportunity to work in a regulated manufacturing and research environment. Ideal for early-career professionals and job opportunities for life science students, this role combines hands-on quality systems experience with exposure to cGMP compliance in one of the world’s leading pharmaceutical organizations.
About Lupin
Lupin is a fast-growing, innovative pharmaceutical company with strong manufacturing, Research & Development, and commercial divisions across the United States. The company maintains a robust generic pipeline and a branded focus on women’s health. Lupin’s first U.S.-based R&D facility is located in Coral Springs, Florida, specializing in generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of fifteen global commercial manufacturing sites and the only U.S. commercial manufacturing facility for Lupin. Lupin prides itself on being people-focused, measuring success by the impact made on the lives of customers and patients.
Job Details:
- Job Title: Quality Assurance Associate
- Company: Lupin Pharmaceuticals
- Location: Coral Springs, FL
- Employment Type: Full-time
Role Summary
The Quality Assurance Associate independently performs quality-related tasks with minimal supervision, ensuring compliance with Lupin’s Quality Assurance programs, procedures, and applicable regulatory requirements. This role supports the maintenance and continuous improvement of Quality Systems while ensuring Laboratory and Manufacturing operations comply with current Good Manufacturing Practices (cGMPs), regulatory standards, and company policies.
Essential Duties and Responsibilities
- Participate in the design, development, and continuous improvement of Lupin’s Quality Systems
- Issue GMP documents, including logbooks, notebooks, and batch records
- Inspect and release cleanrooms following cleaning activities
- Inspect and release GMP areas prior to manufacturing operations
- Inspect incoming materials, in-process materials, and finished products
- Review cGMP documentation, including specifications, SOPs, test methods, and batch records
- Support internal and third-party audits at the LIR site
- Facilitate quality-related training and mentoring
- Collaborate with cross-functional teams, including Operations, Product Development, Quality Control, Engineering, Facilities, Manufacturing, and Supply Chain, to maintain compliance
- Support employee training programs
- Manage QA retain samples and archive GMP documentation
- Support investigations and Root Cause Analysis documentation
- Perform additional QA duties as assigned
Education & Experience For Quality Assurance Job
- Bachelor’s degree (B.S.) in Biology, Microbiology, or a related field preferred
- 1–3 years of experience in an FDA-regulated pharmaceutical or medical device manufacturing environment
- Thorough knowledge of cGMP regulations applicable to drugs and medical devices
- Experience supporting laboratory and manufacturing quality assurance functions
Skills & Abilities
- Ability to enforce compliance with internal quality policies, procedures, and cGMP requirements
- Strong interpersonal skills with the ability to work across diverse departments
- Team-oriented with the ability to clearly communicate regulatory requirements
- Strong oral and written communication skills in English
- Availability to work second shift
Physical Requirements
- Ability to stand, walk, sit, and use hands and fingers
- Ability to reach with hands and arms; talk and hear
- Occasional bending, kneeling, crouching, stooping, or crawling
- Ability to lift up to 15 pounds occasionally
- Work is generally performed in an office environment.
