Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug product manufacturing, including liquid and lyophilized vials, prefilled syringes and secondary packaging, and an array of support services all at a single facility in Bloomington, IN. Founded in 2004, Cook Pharmica is a division of Cook Medical, the world's largest privately held medical manufacturing company.
To perform inspection and sampling of incoming components, raw materials, active pharmaceutical ingredient (API) bulk drug substances, and formulated finished drug product and to maintain the sample management program for raw materials and retained samples.
Essential Job Functions/Duties
• Coordinate with individuals in various departments including Manufacturing Operations, Supply chain, and Quality Control to prioritize incoming material inspections and sampling in order to meet the production schedule
• Maintain a regular and up to date inspection and sampling schedule
• Perform inspections and sample collection on incoming materials according to CGMP and Cook Pharmica SOPs
• Recognize nonconforming material
• Maintain QC inspection/sampling records and primary data in accordance with company procedures and applicable regulations
Minimum Work Experience/Educational Requirements
•Training or experience with component and raw material inspection and sampling in the biotechnology/Pharmaceutical industry is preferred.
• Strong understanding of biotechnology pharmaceutical industry guidelines and regulations (e.g., ANSI) preferred
•Basic technical writing skills preferred
• High school diploma or GED
• Ability to work weekends and off-shift hours as needed to support manufacturing activities
Physical Requirements/Work Environment
• Majority of day spent on feet in warehouse setting or environmentally controlled sampling suite
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position
• Must be able to lift/push/pull 30 pounds on a consistent basis
• Regular exposure to and use of hazardous chemicals
• Requires an eye exam if performing inspections (corrected 20/20 vision necessary)
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...