Contract Quality Assurance Documentation Associate

Overview

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 twelve 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.

Responsibilities

Role and Responsibilities

The Contract Quality Assurance Documentation Associate is responsible for specializing in record keeping. In general, this support will consist of the following tasks:

• Support compliance with compiling documents and tracking submissions for internal and external audits
• Provide support to audit team during external audits by setting meetings, taking notes, compiling documents and making copies as requested
• Assist with the site record retention activities:
• Review records in storage to identify what needs to be discarded
• Issue and maintain notebooks and manufacturing related logbooks
• Scanning of all GMP documents and record keeping
• Issue batch records as required
• Data entry for documentation and training purposes
• Completing other duties as assigned

Qualifications

Qualifications and Education Requirements

• Associates or high school degree
• Experience working in cGMP environment or pharmaceutical industry preferred but not required 
• Strong writing skills, Proficiency with MS Office, Expert level in Excel, Organization skills.

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.

Search Firm Representatives Please Read Carefully 

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails

#LI-DNI