Our client 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. Our client 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 twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States, as well as additional Research and Development teams. Our client 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.
This is a cross functional position encompassing, but not limited to the Dispensing, Granulation, Compression/Encapsulation/Tooling, Film Coating, Wurster Coating, and Liquid manufacturing processes. Must be able to keep accurate and detailed records, understand batch records and maintain cleanliness of work area. Must follow standard operating procedures for the packaging operation. Utilizing the current dispensing systems of scales and balances, accurately weigh/dispense and label raw materials for manufacturing. Accurately prepares for return to the warehouse all partial raw material containers, defaces and disposes of all empty raw material drums as per current SOP s. Checks for accuracy all materials delivered from the Dispensing area as well as all in-process materials from the prior unit operation as per current SOP. Performs all the duties necessary to granulate and compound drug products which includes the setup and use of manufacturing equipment Performs all the duties necessary to compress and encapsulate drug products which includes the setup and use of manufacturing equipment such as but not limited to Tablet Presses, Capsule Fillers, Dedusters, Metal Detectors, Disintegration Testers, Friabilators, tablet and capsule in process Weight Check Systems, Hardness Testers and Micrometers. Performs all the duties necessary to maintain Compression and Encapsulation tooling including, but not limited to Receipt, Measurement, Storage, and Issuance of required tooling. Performs all the duties necessary to Film Coat drug products which includes the setup and use of manufacturing equipment such as but not limited to various size Coating Pans, Solution Tanks, Spray Guns and Mixers. Will maintain the immediate work area in a clean and safe manner, and perform room and equipment cleanings as needed. Reports to manufacturing management. Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures. Comprehends and adheres to all cGMP s and other Regulatory requirements. Comprehends and adheres to all related SOP s as well as Batch Records and Protocols. Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure. Completes all required Training activities. Clearly and accurately completes all required GMP documentation. Perform Room and Equipment inspections and completes all pertinent documentation Other duties as assigned
High School Diploma or equivalent. Computer literacy and solid communication skills (in English) are a must. Must demonstrate Basic Math skills. 3+ years working in pharmaceutical manufacturing environment. Solid understanding of cGMP practices and concepts. Mechanically inclined candidates are preferred. Must be capable of lifting up to 30 lbs Grammatical and communication skills, both written and oral to keep others informed of progress and changes in status of work Able to work as part of team and adapt to changes in work duties Detail-oriented, thorough and methodical, and able to follow timeline Performs other duties as assigned 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 warehouse or manufacturing environment.