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 Fifteen 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.

Role Summary

The QA Associate is responsible for the Quality Systems as they relate to Change Controls, Training program, SOPs, Internal and External Audits and Investigating and responding to Customer complaints. This position ensures all Compliance activities are of the highest quality and meet all applicable SOPs and government standards. 

Essential Duties and Responsibilities

• Initiate, review, monitor and track all Change controls throughout the company. Lead a weekly Change Control meeting to ensure all change controls are properly closed in a timely manner
• Perform compliance audits of GMP related activities within the company. Ensure all activities are in accordance with the batch records, departmental SOP’s, GMP and DEA regulations.
• Perform the external audits for vendor qualification program and ensure the vendors are in good compliance status.
• Participate in any customer or regulatory audits at the company and provide the necessary support for the audit.
• Maintain all training records for each employee. Work closely with Department managers to identify training needs and conduct the necessary training. Identify training gaps and notify employees of the required training.
• Track the SOP’s review period and ensure all the SOPs are within the review period and notify the department heads regarding the revision and follow-up with the revision. Revise the general SOPs and train all personnel as necessary.
• Receive, Document, investigate and respond to customer complaints within the allotted timeframe.
• Perform any other activities assigned by the company

Education and Experience

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