Date Posted: July 27, 2016
Employment Type: Contract
Job Id: 6986
This position is responsible for the scheduling of manufacturing operations, obtaining raw materials, completing batch records and performing all manufacturing procedures required for the drug product. Requires an understanding of our client's SOPs, batch documentation and cGMP requirements.
ESSENTIAL FUNCTIONS: (lnclude percentage of time for each) Manufacturing: . Lead Operator Responsibilities: 40 % . Evaluates production schedule to utilize labor efficiently. Schedules operators for work assignments. Sets up orders for manufacturing operations. Reviews, orders, and updates inventory as required for raw materials, components and labeling. . Reviews and orders manufacturing supplies from outside vendors. Reviews completed batch records and records information for Great Plains entry. Completes GP entries. Complete all batch documentation including batch records, performance metrics and logbooks. Manufacturing Responsibilities: 40% . Manufacturing: perform operations associated with the manufacture and packaging of our client's drug products. Manufacture ampoule products, operating automatic equipment as needed. Provide supplies for the manufacturing operation. Perform inspection of product, assembly of final dosage form, and final packaging for shipment. May need to use manual pallet jacks, jig fixtures and automatic equipment. Quality: 10% . Ensure that processes and products conform with established quality standards. Perform investigations into manufacturing deviations and out of specification (OOS) results. Establish and perform routine checks of all in-process testing. Completes all batch documentation in accordance with cGMPs Facility Maintenance: 10% . Perform all required cleaning of our client @ manufacturing facility and equipment. Assists mechanic in maintenance activities as needed . Perform PM's as required for CGMP compliance. Performs other duties as assigned and required.
SKILLS & ABILITIES: (lnclude job complexity, judgement, physical and visual demands.) The Lead Operator performs all automatic and manual manufacturing processes. Must understand all processes and be able to operate all equipment. Must be familiar with client's SOPs and related forms. Manual dexterity required for assembly operations. Physical demands are moderate. This position should be able to lift up to 75 lbs. Performs all principle duties that affect the quality of products and services provided by our client within the guidelines of 21 CFR 2101211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation(CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business. Needs to interface on routine basis, effectively with Manufacturing, R&D, Materials Management, Quality, Finance and Project Management.
EDUCATION AND EXPERIENGE: High School or Trade School Diploma 4-6 years experience in pharmaceutical/biotech/device mãnufacturing environment. Clean Room Experience required. Manual dexterity needed. Understanding of cGMP requirements desired.