Manager, Quality Assurance Operations

Lupin Pharmaceuticals•Somerset, NJ

1d•$100,000 - $130,000

About The Position

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 Role and 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 Qualifications and Education Requirements 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 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

Requirements

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

Responsibilities

Responsible for directly overseeing the Quality Assurance activities in the manufacturing and packaging areas.
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