Date Posted: September 27, 2016
Employment Type: Contract
Job Id: 7140
Manufacturing: perform operations associated with the manufacture and packaging of drug products. Complete all batch documentation including batch records, performance metrics and logbooks. Manufacture ampoule products, operating automatic equipment as needed. Provide supplies for the manufacturing operation. Perform inspection of product, manual assembly of final dosage form and final packaging for shipment. May need to use manual pallet jacks, jig fixtures and automatic equipment.
- Requires an understanding of SOPs, batch documentation and cGMP requirements
- Quality: 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.
- Sanitation: perform all required cleaning of manufacturing facility and equipment.
SKILLS & ABILITIES:
Must be able to understand batch documentation, SOPs and related forms. Good manual dexterity required. Perform all principle duties that affect the quality of products and services within the guidelines of 21 CFR 210/211, 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
EDUCATION AND EXPERIENCE:
High School/Trade School Diploma or equivalent experience with 2-4 years experience in pharmaceutical/biotech/device manufacturing environment.