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 supervise daily operations and correct technical execution of CGMP procedures across multiple packaging lines (approximately 10-25 employees) in the parenteral manufacturing area and to provide training and support to other associates to ensure systems operate in a safe, efficient, and quality-oriented manner.
Essential Job Function/Duties
• Maintain outstanding technical knowledge of process and equipment related activities (including de-nesting, labeling, cartoning, thermoforming, manual and automated inspection, label control, and device assembly)
• Daily review of production schedule and priorities to determine shift assignments, critical actions, need for overtime and materials forecast
• Secure all materials and manpower required to support shift requirements and execute to established targets
• Oversee tasks on the production floor as they are carried out; ensure SOPs and BRs are followed; provide assistance where needed; remove roadblocks
• Communicate end of shift status to incoming shift and management for smooth operations transition; ensure consistency in operation from shift to shift
• Satisfy all requirements related to batch record documentation including thorough and timely review
Minimum Work Experience/Education Requirements
• 4-year degree in life-science, business, related discipline, or equivalent work experience - required
• 2+ years in supervisory position - required
• 1-2 years of experience in process analysis and improvement in a production / manufacturing environment - required
• 3-5 years of pharmaceutical or biopharmaceutical experience - preferred
• Proficient with various/common computer software platforms
• Ability to manage individual project responsibility and team performance responsibility
• Ability to analyze and solve complex problems using both standard problem solving and process improvement tools
• Will require flexible schedule, to work 12 hour shifts day or night, weekends or holidays
Physical Requirements/Work Environment
• Must be able to lift/push/pull 50 pounds on a consistent basis
• Capable of standing for a minimum of 6 hours, stooping, kneeling, climbing
• Potential limited exposure to hazardous chemicals
• Requires an eye exam if performing inspections (corrected 20/20 vision)
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
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...