Associé Aux Opérations D'assurance Qualité (soir) - Quality Assurance Operations Associate (evening)

Quality Assurance Operations Associate (evening)

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The Quality Assurance Operations Associate is responsible for performing environmental monitoring in the manufacturing processing areas with an emphasis on water systems. Will closely interact with and support manufacturing and quality personnel in terms of environmental monitoring. Will interface with Health Canada, FDA or other inspection authorities during cGMP inspections.

Key duties and responsibilities include:

• Perform environmental monitoring in the manufacturing processing areas with an emphasis on water systems.
• Follow procedures to collect and process environmental monitoring samples such as viable, non-viable, surface, personnel, water and gases as scheduled.
• Prepare supplies required for environmental monitoring and maintain inventory of supplies.
• Perform data review.
• Perform LIMS data entry.
• Perform documentation change control as needed.
• Support and closely interact with manufacturing and quality personnel in terms of all aspects relating to environmental monitoring.
• Follow cGMP and department safety practices.
• Assist with various department tasks.
• Strong knowledge of Health Canada and US FDA cGMP's.
• Demonstrate knowledge of proper aseptic techniques.
• Demonstrate responsibility and accountability in a team environment.
• Strong computer skills; communication and interpersonal skills.
• Detail oriented.
• Must be flexible with working hours.

Qualifications required include:

• Education: High school diploma or equivalent. Associates degree in science desirable.
• Minimum of one (1) year industry experience within Health Canada and/or FDA regulated and biopharmaceutical or devices environment preferred.
• Ability to lift or push up to 25 pounds.
• Ability to stand and/or sit for extended periods - up to four (4) hours at a time.
• Ability to gown and enter into an aseptic/clean room environment.
• Manual dexterity to perform clerical type functions such as typing, using a mouse, copying, faxing, etc.
• Ability to work at a computer and view video display terminal less than 18" away from face for extended periods - up to four (4) hours at a time.
• Ability to read and review documents for extended periods - up to four (4) hours at a time.
• Good oral and written communication skills and good interpersonal skills
• Bilingual in both French and English preferred.