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.

Role Summary

The Quality Assurance Associate / Sr. Associate is responsible for the assurance of proper GMP activities within the Lupin Somerset manufacturing and packaging facilities. This position is responsible for working in production, warehouse, process rooms, and packaging lines to ensure that all manufacturing activities meet the acceptance criteria.  Currently seeking candidates in 2nd shift  (2:00 p.m. - 10:15 p.m. ) 

Essential Duties and Responsibilities

• Sample, inspect incoming raw materials, in-process intermediates, and purchased finished products, and submit samples to the Quality Control laboratory for analysis.
• Label the material status from Quarantine from Release, to reject and vice versa.
• Monitor the manufacturing equipment and rooms, and packaging lines/ equipment for cleanliness and approve them before the start of the operation
• Perform Quality Assurance in-process checks (Beginning, Middle, and End) for manufacturing and packaging operations and determine that the results meet pre-determined standards and batch record requirements.
  Conduct Acceptable Quality Limit inspections on finished dosage forms against pre-determined Quality Attributes.
• Collect and maintain Quality Assurance Retain samples from all products manufactured.
• Assure that all records are stored appropriately for accountability, annual inspection, and retrieval.
• Sample and proofread all pharmaceutical labeling for conformance to the standard.
• Issues approved labels to the packaging lines for use.
• Inform immediately any manufacturing/packaging issue to the Quality Assurance supervisor.

Education & Experience

• An Associate Degree or a Bachelor’s Degree in a scientific field is preferred
• Minimum 3+ years' experience in a Quality Assurance role in the pharmaceutical industry
• Knowledge of the pharmaceutical manufacturing and/or packaging process
• Communication skills: Excellent command of written and spoken English
• Attention to detail is paramount
• Desire to achieve a high quality of work and diligent about following
• Standard Operating Procedures
• Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations.
• SAP, Trackwise, LIMS or similar QMS system knowledge preferred

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 status, or any other classification as required by applicable law.

The anticipated annual base salary range for this position in New Jersey is $45,000 to $70,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.

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 a manufacturing 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.

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