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

GRIFOLS, S.A.•Montreal, QC

3d•Onsite

About The Position

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.

Requirements

High school diploma or equivalent.
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.

Nice To Haves

Associates degree in science desirable.
Bilingual in both French and English preferred. (la maîtrise de l’anglais est requise pour assurer les échanges de documentations et communications avec d’autres sites de Grifols hors Québec et hors Canada (Espagne, USA)

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.