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Quality Assurance Operations Associate

2 months ago

Montreal, Quebec, Canada Grifols, S.A Full time
Job Summary

The Quality Assurance Operations Associate is responsible for performing environmental monitoring in the manufacturing processing areas with an emphasis on water systems. This role will closely interact with and support manufacturing and quality personnel in terms of environmental monitoring. The successful candidate will interface with regulatory authorities during cGMP inspections.

Key Responsibilities
  1. Perform environmental monitoring in the manufacturing processing areas with an emphasis on water systems.
  2. Collect and process environmental monitoring samples, including viable, non-viable, surface, personnel, water, and gases as scheduled.
  3. Prepare supplies required for environmental monitoring and maintain inventory of supplies.
  4. Review and analyze data.
  5. Implement documentation change control as needed.
  6. Support and interact with manufacturing and quality personnel in terms of environmental monitoring.
  7. Adhere to cGMP and department safety practices.
  8. Assist with various department tasks.
  9. Demonstrate knowledge of regulatory requirements, including Health Canada and US FDA cGMPs.
  10. Apply proper aseptic techniques.
  11. Exhibit responsibility and accountability in a team environment.
  12. Utilize strong computer skills, communication, and interpersonal skills.
  13. Be detail-oriented.
  14. Be flexible with working hours.
Requirements
  1. Education: High school diploma or equivalent. An associate's degree in science is desirable.
  2. Minimum of one (1) year of industry experience within a Health Canada and/or FDA regulated and biopharmaceutical or devices environment is preferred.
  3. Ability to lift or push up to 25 pounds.
  4. Ability to stand and/or sit for extended periods - up to four (4) hours at a time.
  5. Ability to gown and enter into an aseptic/clean room environment.
  6. Manual dexterity to perform clerical type functions, such as typing, using a mouse, copying, faxing, etc.
  7. Ability to work at a computer and view a video display terminal less than 18 inches away from the face for extended periods - up to four (4) hours at a time.
  8. Ability to read and review documents for extended periods - up to four (4) hours at a time.
  9. Good oral and written communication skills and good interpersonal skills.