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.
Establish and document rationale for sampling plans, acceptance criteria and measurements systems based on sound statistical principles and industry standards. Review/establish quality parameters and tolerances and make recommendations for improvement to control and assure quality in support of Continued Process Verification requirements.
Essential Job Functions/Duties
• Provide technical support for establishment of sample plans to support development studies, process validation batches and routine production.
• Provide technical support for evaluation of changes for product impact
• Provide Quality oversight of the Continued Process Verification program.
• Perform root cause analysis, problem solving activities, Failure Mode and Effects Analysis (FMEA), Control Plans, Capability Analysis, Correlation Studies, assist with Design of Experiments (DOE) and other Quality Engineering functions as needed
• Gain and share process understanding using Quality Engineering techniques in both Active Pharmaceutical Ingredient (API) manufacturing and Parenteral manufacturing
Minimum Work Experience/Educational Requirements
• Bachelor’s degree or equivalent experience working in a Quality Engineering environment
• Must be familiar with a variety of Quality Engineering concepts, practices, and procedures
• Six Sigma Green Belt preferred
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...