The opportunity
Stability Associate
12 month contract, day shift
Scarborough, Ontario
We are currently seeking a Stability Associate to join our team on a contractual basis.
Working independently under the supervision of the Stability Supervisor, the incumbent having a solid knowledge of statistic concepts, analytical chemistry, and regulatory stability requirements, administers and coordinates activities associated with Teva Canada Stability Programs in a timely, cost-effective, and compliant manner.
Tasks and responsibilities include but are not limited to:
Execute and coordinate the activities of the Teva Canada QC Stability Program by GMPs, cGMP, and standard operating procedures. Ensure stability requirements for various markets are met and programs are administered compliantly. Receives and processes all the stability samples in the Quality Control Laboratory.
Execute the stability program with QC Planners to ensure all samples are tested compliantly.
Maintain the offshoring stability program.
Support the completion of Annual Product Reviews.
Support QA in product release, third-party markets, and private label business.
Your experience and qualifications
Minimum College Diploma in Chemistry or Related Science Discipline
Minimum (3) years of chemistry lab experience in applied statistics, preferably in a chemistry lab environment.
In-depth knowledge of technical requirements for USP/NF, BP/EP, in-house methods, and general laboratory procedures. Good understanding of GMP/cGMP regulations as they apply to laboratories—knowledge of analytical instrumentation.
LIMS (Laboratory Information Management System), MSOffice, Oracle, SmartQC, Statistical software applications / LIMS statistical functions
In-depth knowledge of, and experience with, ICH guidelines GMP/cGMP about laboratories.
Good knowledge of RA / QA business processes
Good knowledge of the business process of laboratory and Quality / Compliance departments
