Manufacturing Associate: Drug Substance - Cook Pharmica
Cook Medical - Bloomington, IN

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As part of the application process, and in order to be considered for this employment position, you must take and receive a passing score on a Work Keys test administered by Work One. You can make arrangements to take the Work Keys test by contacting Work One at 450 Landmark Avenue, Bloomington, Indiana - Ph 812-331-6000 - ask for Cathy x 224 or Brenda x227.

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.

PRIMARY FUNCTION
  • To perform a variety of complex tasks under general guidance and in accordance with current GMP's and to understand the principles behind manufacturing processes.
ESSENTIAL JOB FUNCTION/DUTIES
  • Accurately follow SOP’s for operating production equipment and performing processing steps
  • Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities
  • Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records
  • Operate equipment and techniques related to support, mammalian cell culture and/or harvest and purification
  • Read and follow equipment diagrams
  • Perform operations using a Delta-V process control system
  • Follow procedures needed to support CGMP activities
  • Perform pH and conductivity measurements and filter integrity testing
  • Clean and sterilize processing equipment using automated or manual systems
MINIMUM WORK EXPERIENCE/EDUCATIONS REQUIREMENTS
  • 0-2 years experience working in a GMP environment preferred
  • Perform basic math skills and applications including addition, subtraction, percentage calculations, multiplication and division including the ability to understand decimals
  • Written skills necessary to accurately complete paperwork
  • Ability to use measuring devices and gauges
  • Basic computer entry/retrieval skills
  • High school diploma or GED
  • Will require flexible schedule – able to work 10-12 hour shifts, or night, weekends, or holidays
  • Required to sign confidentiality agreement
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
  • Must be able to lift/push/pull up to 50 pounds on a consistent basis
  • Capable of standing for a minimum of 6 hours, stooping, kneeling, climbing
  • Limited exposure to hazardous chemicals
  • Must be able to wear an air powered or regular respirator
  • Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes will be required in areas associated with this position
  • Majority of day spent in clean rooms requiring full gowning
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 - 21 months ago - save job - block
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About this company
21 reviews
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...