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Lupin Pharmaceuticals · 8 hours ago

Quality Assurance Associate

Coral Springs, FL

Full-time

Onsite

Entry Level

1+ years exp

Lupin Pharmaceuticals is a fast-growing company focused on generic and branded pharmaceuticals, particularly in women’s health. The Quality Assurance Associate will ensure compliance with quality assurance programs and procedures, assist in maintaining quality systems, and support continuous improvement activities within the manufacturing and laboratory functions.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

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

Qualification

CGMP regulationsQuality Systems managementFDA-regulated experiencePharmaceutical manufacturingOralWritten EnglishInterpersonal skillsTeam oriented

Required

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

A minimum of 1-3 years' experience in an FDA-regulated or Pharmaceutical/Medical Device manufacturing environment

Preferred

A Bachelor's Degree (B.S.) in Chemistry, Biology, Microbiology or Pharmacy related field is preferred

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)