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.
ESSENTIAL JOB FUNCTION/DUTIES
- To provide quality control testing of in-process and finished products and environmental monitoring according to SOPs, CGMPs and regulatory guidelines.
MINIMUM WORK EXPERIENCE/EDUCATIONS REQUIREMENTS
- Perform, review and evaluate environmental, critical utility systems, and personnel monitoring
- Perform microbiological in-process and finished product testing
- Provide technical review of data
- Identify atypical data and perform investigation to determine root cause and corrective preventive actions (investigations are to be completed within 30 days of initiation)
- Maintain laboratory records and primary data in accordance with applicable regulations and company policy
- Adhere to the standards of quality ruled by current GMP and the company Quality Policies and site SOPs
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
- Strong written and verbal communication skills to effectively communicate with co-workers as well as management
- Ability to accurately complete necessary documentation
- Basic technical writing skills required; advanced technical writing skills preferred
- Excellent attention to detail
- Ability to work in a team environment and work independently
- High school diploma or GED and 4 years of experience in microbiology or biotechnology industry or AS in biology, microbiology or biotechnology and 2 years of experience in microbiology or biotechnology industry or BA/BS in microbiology or biotechnology or equivalent work experience
- Ability to work at least one Saturday or Sunday per month
- Required to sign a confidentiality agreement and non-compete agreement
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.
- Majority of day spent on feet in the laboratory or clean rooms
- 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 life/push/pull 30 pounds
- Requires an eye exam if performing inspections (corrected 20/20 vision necessary)
- Limited use of hazardous chemicals
Cook Medical - 2 years ago
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...