Job description
Overview:
Qualifications:
COVID19 Vaccination Requirements:
If you are hired, Lupin will require you to prove that you are fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from becoming vaccinated. As an employee, you will be required to follow Lupin policies related to any additional or future COVID-19 vaccination or booster shot requirements.
Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin’s U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams. Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S. Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products. Key shared service functions are found at our beautiful harbor side location in Baltimore, Maryland. Adding to Lupin’s U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Join our U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin’s Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus.
Responsibilities:
The QA Associate is responsible for the assurance of the manufacturing activities within the Lupin Somerset sites. This position is responsible for working in warehouse, process rooms and packaging lines and evaluates all activities meets the acceptance criteria.
This is an opening for our 2nd shift:
- Sample, inspect incoming raw materials, components, in-process, intermediates and finished products and submits samples to the QC laboratory for
- Inspect the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them for use prior to the start of the operation
- Perform QA in-process checks (Beginning, Middle and End) for manufacturing/packaging operations and determine the results meets against pre-determined standards and batch record
- Conduct AQL inspections on incoming materials and finished dosage forms against pre-determined Quality
- Collect and maintain QA Retain samples from all products manufactured. Assure that all retains are stored in an appropriate manner for accountability, annual inspection and
- Sample and proofread all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for
- Inform immediately any manufacturing/packaging issue to the QA supervisor
- Assure all activities are in accordance with the batch records, departmental SOP’s, GMP and DEA regulations.
- Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields.
- Ensure the proper isolation of rejected or defective product/ material generated during batch process and accountability in the batch record.
- Monitor facility and product environmental operating conditions.
- Provide necessary support to conduct root cause analysis for any incidents generated at the facility during all phases of the production and packaging process.
- Perform other QA duties as assigned
Qualifications:
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Bachelor’s Degree in a scientific field
- Minimum 5 years’ experience in a pharmaceutical field.
- Excellent communication skills
- Attention to detail is paramount
- Desire to achieve high quality of work and diligent about following Standard Operating Procedures
- Knowledge of Good Manufacturing Practice
P
HYSICAL
R
EQUIREMENTS
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 25 pounds occasionally. Generally work is performed in a warehouse or manufacturing environment.
COVID19 Vaccination Requirements:
If you are hired, Lupin will require you to prove that you are fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from becoming vaccinated. As an employee, you will be required to follow Lupin policies related to any additional or future COVID-19 vaccination or booster shot requirements.
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