Quality Assurance Associate

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Job Description

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

Essential Duties and 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

Qualification and 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 $63,000, 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.

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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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Competencies

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility