Quality Assurance Associate at Lupin

Location: New Jersey
Type: Full-time
Level: Entry-level
Posted: Dec 3, 2025

Description

The Quality Assurance Associate at Lupin ensures compliance with quality assurance programs and procedures, as well as applicable regulations. This role involves maintaining quality systems, developing new controls, and ensuring that laboratory and manufacturing functions adhere to cGMPs and regulatory requirements. The associate will also participate in designing quality systems, issuing GMP documents, inspecting manufacturing areas and products, supporting audits, and providing quality-related training.

Required Skills

GMP
Quality Systems
Auditing
Documentation
Root Cause Analysis

Additional Information

Minimum Education: A Bachelor ’s Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field is preferred.
Required Previous Experiences: 1-3 years’ experience in an FDA-regulated or Pharmaceutical/Medical Device manufacturing environment.
Preferred Qualifications: 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.