SAS Stability Coordinator

Septodont•Cambridge, ON

12h•Onsite

About The Position

At Septodont, a global leader in dental products and a key player in pharmaceutical development and contract manufacturing (CDMO), we are proud to work every day to improve patients’ health and well-being. Present in more than 110 countries, the Group relies on the energy, expertise, and passion of 2,600 employees. With 6 international production sites, Septodont combines industrial excellence, technological expertise, and innovation to meet the needs of healthcare professionals worldwide. In North America, our operations include facilities in Ontario, Quebec, and Pennsylvania. Our Cambridge, Ontario site is home to Novocol Pharma – a thriving center of innovation with over 40 years of expertise in sterile injectable cartridges and combination product manufacturing. Backed by a team of more than 675 dedicated professionals and modern facilities, we deliver high-quality, customer-focused solutions to partners around the world. Beyond our expertise, our people are our greatest strength. We foster a stimulating work environment where everyone can learn, grow, and build a career that reflects their aspirations, supported by continuous training and internal mobility. As a socially responsible company, we place diversity and inclusion at the heart of our development, convinced that they enhance collective performance and foster human experience. Joining Septodont means becoming part of a human-scale international group and contributing to a meaningful mission: improving health for as many people as possible. What if your next professional chapter started with us? We have an opportunity for a SAS Stability coordinator FUNCTION SUMMARY: The SAS Stability coordinator is accountable to the Stability and Analytical Services Manager and is mainly responsible for managing Stability program, preparing and maintaining technical documents such as protocols, specifications, reports, and SOPs and review of stability data at Novocol Cambridge.

Requirements

University degree in a related science (Chemistry)
Minimum 2 years’ experience in Pharmaceutical industry including stability testing and management of stability program.
Acute attention to detail.
Experience working in a self-directed team environment is essential.
Proven analytical and problem-solving skills with the ability to make recommendations.
Demonstrated organizational skills with the ability manage multiple priorities with minimal direction.
Effective interpersonal and communication skills both verbal and written.
Experienced in using Laboratory Information Management System (LIMS) and Microsoft Office is required.

Responsibilities

Manages stability program and ensures all stability studies are started in a timely manner.
Prepares master schedule for stability studies and update it with new studies.
Generates, manages and supports stability testing schedule.
Monitors production schedule on a weekly basis and requests samples for stability program.
Supports studies related to the post approval changes and maintain product life cycle
Ensures Bulk, FP, validation and stability samples are logged and received in the Lab.
Prepares and updates stability protocols and specifications in Electronic Management System (Ennov and LIMS).
Logs, creates, starts new stability studies and retest in Electronic Management system (LIMS).
Prepares and verify inventory cards and study requests.
Reviews and receives pulled stability sample(s), prints worksheets.
Monitors testing progress of stability sample(s) in LIMS to ensure timely testing and data entry to LIMS.
Reviews stability data and ensures all results meet stability trend.
Manages stability chambers and initiates investigations for temperature and humidity excursions.
Troubleshoots alarms on stability chambers and contacts vendors for chambers repairs.
Prepares and supports Annual Product Quality Review (APQR) for FDA for US/CA/INT markets.
Prepares annual product review reports and assists during the regulatory audits.
Communicates with vendors, request quotations, creates POs, receive invoices and initiates work orders in Electronic Management System (AX and CARL).
Provides stability data and stability trends to regulatory affair department as required.
Prepares and supports preparation of PowerPoint/deck for monthly group meeting.
Provides AX training to SAS, PD and QC staff (as required).
Supports data review and service group release (as required).
Initiates and supports DCR/CCR related to stability studies.
Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.
Observes and supports all safety guidelines and regulations.
Performs other related duties as assigned.