Associé aux opérations d'assurance qualité (Soir) - Quality Assurance Operations Associate (Evening)

Grifols; Montreal; On-site; CAD 40,000 - 55,000; Full time

Job summary

Une entreprise de soins de santé recherche un Associé aux opérations d’Assurance Qualité à Montréal. Le candidat idéal sera responsable de la surveillance environnementale et interagira avec le personnel de qualité. Une expérience dans un environnement réglementé par Health Canada ou la FDA est préférée. La connaissance des techniques aseptiques et des compétences en communication en français et en anglais sont nécessaires.

Qualifications

• Expérience d'un an dans un environnement réglementé par Health Canada et/ou la FDA.
• Capacité à lever ou pousser jusqu'à 25 livres.
• Capacité de travailler dans une salle aseptique/propre.

Responsibilities

• Effectuer la surveillance environnementale dans les zones de fabrication.
• Préparer les fournitures requises pour la surveillance.
• Interagir étroitement avec le personnel de fabrication et de qualité.

Skills

Compétences en communication

Travail d'équipe

Orientation aux détails

Compétences informatiques

Bilingue (Français et Anglais)

Education

Diplôme de lycée ou équivalent

Diplôme associé en sciences (souhaitable)

Job description

Souhaitez‑vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez‑vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien‑être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.

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.

Position Title

Associé aux opérations d’Assurance Qualité (quart du soir 14h30 - 23h00)

Reports To

Superviseur des opérations, Assurance Qualité

Position Summary

The QA Operation 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

• 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

• 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 (English required for documentation and communication with other Grifols sites outside Quebec and Canada – Spain, USA).

Location

North America: Canada: Montreal: Quebec