QC Microbiology Associate - Cook Pharmica
Cook Medical - Bloomington, IN

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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 Functions/Duties
• Perform, review and evaluate environmental, critical utility systems, and personnel monitoring
• Perform microbiological in-process and finished product testing
• Provide technical review of data collection
• Act as department lead on projects and environmental investigations
• Identify atypical data and perform investigation to determine root cause and corrective preventive actions (investigations are to be completed within 30 days of initiation)
• Develop and execute validation protocols for new methodology
• 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
• Must work and interact effectively with and for others to achieve
company goals
• Must strictly adhere to safety requirements
• Must meet company attendance requirements
• Must maintain company quality and quantity standards
• Must have effective oral and written communications throughout various
levels of the organization
• Ability to work in collaborative and independent work situations and
environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

Minimum Work Experience/Educational Requirements
• Previous experience with various instrumentation/methodologies, environmental monitoring, endotoxin and bioburden testing, microorganism identification and aseptic technique
• Experience with microbiological method validation is desired
• Experience in a GMP-regulated environment is desired
• Ability to accurately complete necessary documentation
• Computer proficiency required
• BA/BS in biology, microbiology or biotechnology or equivalent work experience is required
• 2-4 years experience in microbiology or the biotechnology industry is desired
• Ability to work at least one Saturday or Sunday per month
• Required to sign a confidentiality agreement and non-compete agreement

Physical Requirements/Work Environment
• 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 lift/push/pull 30 pounds
• Requires an eye exam if performing inspections (corrected 20/20 vision necessary)
• Limited use of hazardous chemicals

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.

Cook Medical - 18 months ago - save job - - block
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