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Lupin Pharmaceuticals · 5 hours ago

Manager, Quality Assurance Operations

Somerset, NJ

Full-time

Onsite

Mid, Senior Level

$100K/yr - $130K/yr

5+ years exp

Lupin Pharmaceuticals is a fast growing company focused on manufacturing, Research and Development, and commercial divisions in the pharmaceutical industry. The Manager of Quality Assurance Operations will oversee Quality Assurance activities in manufacturing and packaging, ensuring compliance with GMP and SOP procedures while managing a team of Quality Assurance Technicians.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

Responsibilities

Conduct Manufacturing and Packaging deviation investigations when a deviation occurs, including writing the investigation reports. Appropriately route written investigations through QA management channels in a timely manner

Conduct ongoing performance reviews and evaluations for shift Quality Assurance Technicians including coaching and mentoring to further develop skills and knowledge

Manage the scheduling of the shift Quality Assurance Technicians, properly manage requests and receive management approval for overtime when needed

Proactively make recommendations for SOP updates, as well as seek opportunities to identify efficiencies in the daily Quality functions

Ensure proper GMP compliance and SOP procedures are followed at all times, as well as follow all safety and environmental guidelines

Oversee, and at times perform hands-on sampling, inspecting of incoming raw materials, in-process intermediates and purchased finished products and submitting samples to the QC laboratory for analysis

Manage the material status from Quarantine to Release/Reject and vice versa

Monitor the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them prior to the start of the operation

Supervise and at times 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 requirements

Appropriately guide the QA Technician team to perform AQL inspections on finished dosage forms against pre-determined Quality Attributes

Manage the collection and maintenance of samples from all products manufactured. Assure that all retains are stored in an appropriate manner for accountability, annual inspection and retrieval

Oversee the sampling and proofreading of all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use

Utilize software programs such as QAMS, SABA (LMS), and SAP for various tracking of daily work activities as well as training

Immediately address any Quality issues brought forward by the Quality Assurance Technicians

Perform other QA duties as assigned

Qualification

Quality Assurance experienceGMP complianceTeam managementBachelor’s DegreeSoftware proficiencyMethodical approachCommunicationAttention to detailMentoring skillsAdaptability

Required

5+ years' prior experience in a Quality Assurance role, preferably with experience managing others

Bachelor's Degree in a scientific or related field

Excellent communication skills

Attention to detail is paramount

Desire to achieve high quality of work and diligent about following Standard Operating Procedures

Able to effectively manage and mentor a team and adapt to changes in work duties

Detail-oriented, thorough and methodical, and able to follow timeline

Benefits

Discretionary performance bonus

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)