Quality Assurance Associate

Lupin Pharmaceuticals•Somerset, NJ

13d•$45,000 - $63,000•Onsite

About The Position

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. Role Summary The QA Associate is responsible for the assurance of the manufacturing activities within the Lupin Somerset sites. This position is responsible for working in the warehouse, process rooms, and packaging lines and evaluates all activities meets the acceptance criteria. This position will require 2nd shift hours: 2:00 p.m. - 10:30 p.m. Monday - Friday

Requirements

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.

Nice To Haves

SAP, Trackwise, LIMS or similar QMS system knowledge preferred

Responsibilities

Sample, inspect incoming raw materials, components, in-process, intermediates, and finished products and submits samples to the QC laboratory for analysis.
Inspect the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them for use before 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 attributes.
Collect and maintain QA Retain samples from all products manufactured. Assure that all retains are stored appropriately for accountability, annual inspection
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 QA supervisor
Assure all activities are following 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 the 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