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 and Responsibilities

The Batch Record Reviewer will report to the Director of Quality Assurance and will work cross-functionally within the Production, Packaging, and Product Development departments to review Master Batch Records and Completed Batch Records, exhibit Batch records and intended batch records. The Reviewer will ensure all work is performed and documented according to approved Standard Operating Procedures, in general compliance with cGMP by reviewing batches and cross-checking against specifications. The Reviewer will also perform in-process data reviews.  Working in a timely manner is imperative. Partner with project management, supply chain, QA, and QC to effectively plan and execute all projects in manufacturing

• Review batch records; cross-check against specifications for accuracy, completeness, and to identify any potential issues
• Upon identification of variances, notify proper department Supervisors
• Prepare department-specific metrics for management review.
• Review proposed Manufacturing and Packaging batch records.
• Perform data entry activities for department databases and/or logbooks.
• Assist in compiling data for the annual product review.
• Compiling APR for commercial products.
• Cross Train on in process quality activities 

Qualifications and Education Requirements

• Associates’ Degree in a Scientific field, Bachelor’s preferred
• 1+ year(s) prior experience working in a GMP environment, pharmaceutical company preferred
• Batch Record Review experience preferred
• Excellent computer skills; Word, Excel
• Experience with SAP a plus
• Grammatical and communication skills, both written and oral to keep others informed of progress and changes in status of work
• Able to work as part of team and adapt to changes in work duties
• Detail-oriented, thorough and methodical, and able to follow timeline

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