Quality Assurance Associate- Complaints

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

The QA Associate, Complaints is responsible for all the customer complaint activities within Lupin Research, Inc., Coral Springs. This position is responsible for assessing complaint samples and reporting information to Quality Assurance.

Follow procedures applicable to Market Complaints consistent with Lupin Research, Inc. Responsible for assuring all product quality complaints are appropriately initiated, investigated and responded to in accordance with Lupin Research, Inc. procedures Work with external partners and customers to determine, to ensure the gathering of information necessary for robust root cause analysis Collaborate with functional departments to identify additional procedural controls for overall improvement of compliance Any other duties as assigned by Functional Manager

Qualifications

Associates’ Degree in a scientific field Good understanding of the current regulatory requirements pertaining to market complaints Strong working knowledge of market complaints and root cause analysis process preferred Excellent technical writing skills and command of the English language Experience working with Electronic Quality Management Systems such as TrackWise, Master Control, Veeva, ETQ etc. preferred Ability to work with computers and software applications like Microsoft Word and Excel

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.

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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