QA Operations Associate

7 months ago

Montréal, Canada G Canada Therapeutics Full time

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

**Position Title**:QA Operations Associate

**Reports to**: QA/Quality Systems & Compliance Manager

**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

**Titre du poste**:Associé aux opérations d’AQ

**Relève de**: Chef, AQ/Systèmes Qualité & Conformité

**Résumé du poste**

**L’Associé aux opérations d’AQ **est responsible pour effectuer une surveillance de l’environnement (EM) dans les zones de la fabrication en mettant l’accent sur les systèmes d’eau. Interagir étroitement avec le personnel de fabrication et de qualité et le soutenir en termes de surveillance environnementale. Répondre aux questions de Santé Canada, FDA ou d’autres autorités d’inspection pendant les inspections des BPF.

**Principales tâches et responsabilités**
- Effectuer une surveillance environnementale dans les zones de traitement de la fabrication en mettant l’accent sur les systèmes d’eau.
- Suivre les procédures de prélèvement et de traitement des échantillons de surveillance environnementale tels que les échantillons de surveillance environnementale viables, non viables, de surface, de personnel, d’eau et de gaz selon les cédules.
- Préparer les fournitures nécessaires à la surveillance environnementale et tenir à jour l’inventaire des fournitures.
- Effectuer la révision des données.
- Entrer des données dans LIMS.
- Effectuer le changement de contrôle de documentation si nécessaire.
- Soutenir et interagir étroitement avec le personnel de fabrication et de qualité en termes de tous les aspects liés à la surveillance environnementale.
- Suivre les BPF et les pratiques de sécurité du département.
- Assister à diverses tâches du département.
- Solide connaissance des BPF de Santé Canada et de la FDA.
- Démontrer la connaissance des techniques aseptiques appropriées.
- Démontrer la responsabilité et l’imputabilité dans un environnement d’équipe.
- Solides compétences en informatique; compétences en communication et en relations interpersonnelles.
- Soucieux des détails.
- Doit être flexible avec les heures de travail.

**Qualifications requises**
- Études: DEC ou l’équivalent. Diplôme d’associé en sciences souhai

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