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 assist with GMP activities, documentation and reports with a focus area of drug product.
Essential Job Functions/Duties
• Review documentation for accuracy and compliance to procedures
• Maintain quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products.
• Perform administrative review of batch data for accuracy and compliance to procedures for raw material, in-process and product release
• Review and approve QC product testing documentation supporting batch release
• Perform exception, corrective and preventive action, and batch record review
• Support AQL’s for inspection
• Support QA record keeping and record processing activities
• Provide administrative support to batch release activities
• Perform item master review and approval for non-product contact items
Minimum Work Experience/Educational Requirements
• High school diploma/GED and 2-4 years of experience in Microbiology or Biotechnology industry OR Associates Degree in Biology, Life Sciences or related field and 0-2 years of experience in Microbiology or Biotechnology industry OR equivalent work experience
• Previous experience in technical review of records preferred
• Previous Quality Assurance experience preferred.
• Have the written skills to accurately complete paperwork
• Excellent attention to detail
• Basic understanding of applicable regulations
• Knowledge of Good Manufacturing Practices applications
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...