Current jobs related to Metrologist - Somerset, New Jersey - Lupin Pharmaceuticals

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 womens 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 twelve 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.

Role Summary

The Metrologist will report to the Quality Control Manager, The Sr. Metrologist at Lupin Somerset is expected to perform or assist with all essential tasks including preventative maintenance, repairs, calibration, and qualification of instruments in accordance with all applicable SOPs to ensure adherence to cGMP in support of the Quality Control laboratory operation. Develops and implements procedures, systems, and training activities to ensure the successful execution of the project. Provides training, technical expertise, and support to the laboratory staff. Assist with investigations due to anomalous or OOC results.

Essential Duties and Responsibilities

• Life cycle management of Lab instruments such as but not limited to commissioning, movement, replacement, maintenance, Organization and decommissioning of Lab and GMP instruments and continuous improvements
• Involvement, planning review and execution of Qualifications(DQ/IQ/OQ/PQ) and calibrations
• Calibration, maintenance, and troubleshooting of laboratory equipment such as but not limited to HPLC, UPLC, GC, Dissolution, Malvern, FT-IR, Potentiometer, Karl Fischer, Physical test equipment, Nasal spray analysis equipment, different types of detectors including but not limited to RI, conductivity, Dionex, etc.
• Maintain instrument inventories with status of PM and calibration dates, manages vendor activities
• Review/approve master Preventive Maintenance/Calibration schedule
• Planning, execution, and review of instrument calibration/qualification-related activities as per the calibration master plan
• Preparation, execution, review, approval of Change controls, CAPA-related activities, Standard Operating Procedures and assist and conduct deviations and investigations
• Schedule and manage outside contractor visits for preventive maintenance or repair and review vendor calibration reports.
• Collaborate with colleagues and internal and external departments and partners to achieve primary department goals.
• Exercise strong problem-solving ability and troubleshooting of laboratory instruments.
• Concurrent documentation of all raw data and observations and Raw data and report review for calibration/qualification
• Adhere to cGMP and safety procedures
• Notify management of any observations or deviations
• Other duties as assigned.

Education & Experience

• Bachelor's Degree in a Scientific Field
• 8-10 years of pharmaceutical industry experience working in a laboratory
• Experience with calibration and maintenance of laboratory equipment such as GC, HPLC, UPLC, dissolution apparatus, FTIR

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 to 15 pounds occasionally. Generally work is performed in a laboratory environment.

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, veterans status, or any other classification as required by applicable law.

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