This is a cross functional position encompassing, but not limited to the Dispensing, Granulation, Compression/Encapsulation/Tooling, Film Coating, Hot Melt Extrusion, Chemical and Sterile manufacturing processes.
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 SOPs 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.
Manual Dexterity is required.
Other duties as assigned
Request all required raw materials from the warehouse for dispensing and verifies the identity of the materials for accuracy and compliance.
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 such as but not limited to Granulators, Mixers, Fluid Bed Dryers, Tray Dryers, Comil’s, Fitzmills, Steam Kettles, Sample Tools, Moisture Balances, Thermometers and Pumps.
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.
Performs all the duties necessary to manufacture extruded drug products which includes the setup and use of manufacturing equipment such as but not limited to hot melt extruders, powder feeders and handling equipment. The job requires the assembling, disassembly and cleaning of hot melt extruder heating segments and dies.
Performs all the duties necessary to manufacture Sterile and Chemical drug products which includes the setup, preparation, cleaning and autoclaving of manufacturing and packaging equipment including various mixers, pumps and tanks under aseptic conditions as required.
Will properly clean, label and transport all in process and finished product to the designated storage area, will maintain the immediate work area in a clean and safe manner, and perform room and equipment cleanings as needed.
Must be able to move materials weighing up to 50 lbs
May be required to twist/bend
Must be able to move about the production area and facility
Must be able to remain in an upright position for extended periods of time
Must be able to ascend/descend a ladder
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.