Manager, Quality Assurance Operations - Somerset - Lupin Pharmaceuticals

    Lupin Pharmaceuticals
    Lupin Pharmaceuticals Somerset

    1 day ago

    $80,000 - $135,000 (USD) per year *
    Description
    Overview
    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 Fifteen 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.
    Responsibilities
    The Manager Quality Assurance Operations reports to the Quality Assurance Director and is responsible for directly overseeing the Quality Assurance activities in the manufacturing and packaging areas. This Supervisor will be responsible for monitoring the activities of the shift Quality Assurance Technicians including in-process sampling of multiple finished dosage forms, incoming raw materials and component sampling, and proper documentation of all Quality Assurance functions.
    • 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
    Qualifications
    • 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
    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.
    The anticipated annual base salary range for this position in New Jersey is $100,000 to $130,000, 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 an office environment.
    Search Firm Representatives Please Read Carefully
    * This salary range is an estimation made by beBee
  • Work in company

    Quality Assurance Operations

    Only for registered members

    The primary responsibility of this role is to ensure quality oversight and compliance with GMPs and GDPs for Clinical Supply Chain Logistics. · ...

    New Brunswick

    1 month ago

  • Work in company

    Manager, Quality Assurance Operations

    Only for registered members

    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 he ...

    Somerset, NJ $80,000 - $135,000 (USD) per year

    3 days ago

  • Work in company

    Quality Assurance Operations Specialist

    Only for registered members

    We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. · ...

    Somerset, NJ

    1 month ago

  • Work in company

    Quality Assurance Operations Specialist

    Only for registered members

    We are looking for skilled professionals eager to grow their careers in an exciting and fast-paced environment.We foster a communicative environment where mutual respect, accountability, and excellence empower our team. · As an international organization, · we help you navigate a ...

    Somerset $80,000 - $90,000 (USD)

    1 month ago

  • Work in company

    Quality Assurance Operations Specialist

    Only for registered members

    +Job summary · We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. · + · ResponsibilitiesRoutine auditing of the Manufacturing Facility area to ensure compliance with cGMPS. · Provide QA support to manufact ...

    Somerset $80,000 - $90,000 (USD)

    1 month ago

  • Work in company

    Quality Assurance Operations Auditor

    Only for registered members

    We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. · Routine auditing of the Manufacturing Facility area to ensure compliance with cGMPS · Provide QA support to manufacturing for clinical and commercial ba ...

    Franklin Township $80,000 - $90,000 (USD) Full time

    1 month ago

  • Work in company

    Quality Assurance Operations Specialist

    Only for registered members

    We are looking for skilled Quality Assurance Operations Specialists to support our manufacturing facility. As a key member of our team you will ensure compliance with cGMP regulations. · ...

    Franklin Township $80,000 - $90,000 (USD) Full time

    1 month ago

  • Work in company

    Quality Assurance Operations Auditor

    Only for registered members

    We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. · We foster a communicative environment where mutual respect, accountability, and excellence empower our team. · The Ardena Business Unit based in Somerse ...

    Somerset, NJ

    1 month ago

  • Work in company

    Assurance Product Operations Manager

    Only for registered members

    Job Description · At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact. Whether you're starting out in your career or taking your next step as a seasoned professional, the EisnerAmper experience is one-of-a-kind. You ...

    Iselin, NJ

    5 days ago

  • Work in company

    SVP, Threat Operations – Cyber Security Assurance

    Only for registered members

    Company Overview: · A leading global sovereign wealth fund with over 2,000 employees across 12 locations worldwide is seeking an SVP Threat Operations to join their Technology Group. This role will focus on providing leadership and management for the organization's cybersecurity ...

    New York

    2 weeks ago

  • Work in company

    Assurance Operations Intern - Summer 2026 (New York)

    Only for registered members

    Job Summary · JOB DESCRIPTION · The Assurance Operations Intern has direct interaction and works directly within the assurance practice partnering with the Organizational Development team within People and Culture team adding value to the operations of our national office. We ar ...

    New York $36 - $40 (USD)

    16 hours ago

  • Work in company

    Assurance Operations Intern - Summer 2026 (New York)

    Only for registered members

    Description · Job Summary: · The Assurance Operations Intern has direct interaction and works directly within the assurance practice partnering with the Organizational Development team within People and Culture team adding value to the operations of our national office. We are pa ...

    New York, NY, United States

    1 hour ago

  • Work in company

    Assurance Operations Intern - Summer 2026 (New York)

    Only for registered members

    Job Summary: · The Assurance Operations Intern has direct interaction and works directly within the assurance practice partnering with the Organizational Development team within People and Culture team adding value to the operations of our national office. We are passionate about ...

    New York, NY

    1 day ago

  • Work in company

    QA Specialist II

    Only for registered members

    · SUMMARY: · This position is primarily responsible for coordinating and directing quality assurance programs and reviewing, preparation/maintenance of SOPs, calibration and other controlled document to ensure accuracy, completeness, and adherence to establishment standards by p ...

    Somerset, NJ, US $65,000 - $105,000 (USD) per year

    4 days ago

  • Work in company

    Director of Global Quality Assurance Validation

    Only for registered members

    · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allo ...

    Somerset, New Jersey, United States

    6 days ago

  • Work in company

    Director of Global Quality Assurance Validation

    Only for registered members

    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogen ...

    Somerset, New Jersey, United States

    5 days ago

  • Work in company

    Prototype and Sample Supervisor

    Only for registered members

    Prototype & Sample Supervisor · About CompoSecure CompoSecure, a GPGI business (NYSE: GPGI), is the leading manufacturer of Premium Metal Payment Cards and also offers best-in-class Authentication and Digital Asset solutions. The Company's offerings combine elegance, simplicity, ...

    Davidson Ave Somerset, New Jersey, United States

    4 days ago

  • Work in company

    Quality Manager Somerset, New Jersey

    Only for registered members

    The Quality Assurance (QA) Manager leads both the Quality Assurance and Site Sanitation teams at Solina's Somerset facility. · This role is responsible for developing implementing maintaining food safety quality sanitation programs to ensure production safe high-quality dressings ...

    Somerset, NJ

    2 weeks ago

  • Work in company

    Director of External Manufacturing Quality

    Only for registered members

    · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allo ...

    Somerset, New Jersey, United States

    6 days ago

  • Work in company

    Director of External Manufacturing Quality

    Only for registered members

    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogen ...

    Somerset, NJ

    1 week ago

  • Work in company

    Security Operations Manager

    Only for registered members

    We are seeking a Manager, Cybersecurity to lead core security operations, including SOC oversight, vulnerability management, DFIR, threat intelligence integration, partner management and red team coordination. This role requires working on-site five days per week in Somerset NJ. ...

    Somerset, NJ

    3 weeks ago

Jobs
>
Manager quality assurance operations
>
Jobs for Manager quality assurance operations in Somerset