Career Connections Canada Inc.
'Connecting great people with great companies'
Our client in Brampton is seeking a Stability Associate to join their team.
What They Offer:
- A safe and clean; GMP regulated work environment
- Opportunities for career growth and development
- A competitive wage/salary
- Incentive bonus programs that are designed to reward employees for their individual contributions
- Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
- Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs
The main responsibility of this position is to support routine stability administration and prepare technical reports to support Annual Stability Reviews in compliance with SOP’s, Health Canada and FDA requirements. This position acts as an active influence towards elevating the quality practices and guidelines for manufactured and packaged product at the facility.
Principal Duties and Responsibilities :
- Maintenance of stability chambers- daily checks coordinates Preventative Maintenance and Calibration of these chambers.
- Maintain stability samples inventory and responsible for daily sample pulls from the Stability Chamber and delivering to QC lab.
- Preparation of stability protocols, updating LIMS with protocol and obtain review and approval.
- Preparation of monthly sample Pull list and adherence to published schedule.
- Preparation of Annual Stability commitment list.
- Initiation of stability studies in Stability database
- Initiate sample disposal after completion of studies
- Compile and/or review stability data in tabulated and graphical representations and assess product stability attributes. Ensures stability data available for stability summary reports meet established specifications and deviations are investigated
- Prepares graphical presentations of stability data
- Verifies the correctness and validity of sample information/testing requirements entered into the stability database during stability initiations
- Verifies the correctness and validity of sample information in creation of monthly stability pull lists
- Prepare Annual Stability Summary reports for Regulatory Submissions
- Initiate Change Controls and/or CAPAs as required as a result of the annual stability review.
- Other duties as assigned.
Other Duties and Responsibilities:
- Retrieve data from various sources (Change Controls, investigations, rejects, complaints etc.) both electronic and hard copy.
- Prepare reports and spreadsheets in standardized formats.
- Archival of stability documents (Initiation packages, COAs etc.)
Knowledge, Skills and Abilities
- BSc in Chemistry
- Minimum 2 years of experience with the Pharmaceutical industry combined with knowledge of compliance requirements for the pharmaceutical industry.
- Strong technical writing ability in a scientific discipline.
- Ability to analyze data utilizing statistical data software preferred
- Proficiency with applicable computer software (Word, Excel)
- Ability to communicate and work effectively in a team-based environment combined with good written and oral communication skills.
- Strong organizational and multi-tasking ability in order to accommodate changes in priorities.
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections