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 fiften 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.
ResponsibilitiesRole Summary
The Quality Assurance Technician 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 evaluate all manufacturing activities meet the acceptance criteria.
Essential Duties and Responsibilities
Sample, inspect incoming raw materials, in-process intermediates, and purchased finished products and submits 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 operationPerform Quality Assurance in-process checks (Beginning, Middle, and End) for manufacturing and packaging operations and determine the results meets against pre-determined standards and batchrecord requirements.Conduct Acceptable Quality Limit inspections on finished dosage forms against pre-determined QualityAttributes.Collect and maintain Quality Assurance Retain samples from all products manufactured.Assure that allretains are stored appropriately for accountability, annual inspection, and retrieval.Sample and proofread all pharmaceutical labeling for conformance to the standard.Issues approvedlabels to the packaging lines for use.Inform immediately any manufacturing/packaging issue to the Quality Assurance supervisor. Qualifications
Education & Experience
Associate Degree or Bachelor’s Degree in a scientific field is preferred3+ years' experience in a Quality Assurance role in the pharmaceutical industryKnowledge of the pharmaceutical manufacturing and/or packaging processExcellent communication skillsAttention to detail is paramountDesire to achieve a high quality of work and diligent about followingStandard Operating ProceduresKnowledge of Good Manufacturing Practices
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. In general the activity level one usually performs is light physical activity performing non-strenuous daily activities of an administrative and sedentary nature. This position may require lifting up to 25 pounds occasionally. Generally work is performed in a manufacturing or warehouse environment.
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 50 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
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.