Stability Coordinator

Job Description

Job Description

Job Description

G.W. Seier founded Vita Health Products in Winnipeg, Manitoba in 1936. Since then, the company has grown from a small mail-order operation selling herbs and patented medicines into one of Canada’s foremost suppliers of over the counter (OTC) pharmaceutical products and natural health products.

Based in Winnipeg – the geographic centre of Canada – and located in the St. Boniface industrial park, IVC Vita Health Products is a vertically integrated manufacturer, marketer, and distributor of a broad line of high-quality, nutritional supplements, and over the counter medications throughout Canada, with over 260,000 square feet of manufacturing, packaging, and distribution facilities.

IVC Vita Health has a long and proven track record of success and continues to demonstrate strong results with consistent growth. IVC Vita Health is part of the IVC Nutrition Corporation of Companies.

At IVC Vita Health understand the importance of a comprehensive benefits package to attract and retain top talent. Our offerings include:

• Competitive salary and performance-based annual bonuses.
• Company paid health, dental, and vision insurance.
• Retirement savings plan with employer matching.
• 7 Paid Personal Leave Days per year.
• Professional development opportunities and tuition reimbursement.
• Employee assistance programs for mental health and well-being.
• Company-sponsored social events and team-building activities.

Join us at IVC Vita Health and be part of a team that values your contributions and invests in your success. We are committed to creating a workplace where diversity is celebrated, and every team member can thrive both personally and professionally.

Our Vision: The Canadian partner driving self-care innovation to enrich health.

Job Summary:

As the Stability Coordinator, you will be responsible:

• Create stability pull lists for each month & Perform stability samples pulls timely as per schedule.
• Coordination of sample testing with QC and Contract Laboratories as per the stability protocols to ensure testing is completed within defined stability testing window and resolve queries involving data integrity review of documents for release.
• Generate stability protocols in SLIM, enroll and activate studies.
• Analysis of stability data using Stability Information Management System (SLIM), perform trend analysis.
• Prepare/Review stability specification documents to ensure compliance.
• Prepare/Review stability protocols for commercial, validation, trial, and on-going continuing stability studies for ANDS, OTC, NHP and THMP products.
• Prepare/Review stability reference document (SRD) and stability shelf-life document (SSD) reports for annual new drug submissions (ANDS), OTC-DIN, NHP and THMP.
• Monitoring, verification, and data management of temperature and humidity of stability chambers.
• Initiate CCRs & deviations as required.
• Assist QA & compliance by preforming stability assessments on OOS laboratory results to support stability nonconformance, CAPAs and deviations.
• Prepare/Review Stability OOT reports and ensure SLIM stability software is updated.
• Coordinate with Operations and Quality Control to reduce the potential for short, dated inventory by coordination of testing product to extend shelf life via SRD reports and initiation of change controls (CCRs)
• Support Regulatory Affairs by providing stability data for submission of regulatory documents.
• Assist QA & compliance by preforming stability assessments on OOS laboratory results to support stability nonconformance, CAPAs and deviations.
• Identify and report any out of trend or out of specification data. Prepare Stability OOT reports and ensure SLIM stability software is updated.
• Perform SLIM audit trail review.
• Perform stability sample disposal for completed studies and ensure stability chambers are clean and organized.
• Update shelf life in M2M.
• Perform additional duties as assigned.

Experience

• Experience with statistical trending to evaluate stability profiles, justify shelf life and specifications (i.e. Excel)
• Sound working knowledge of GMP, ICH, Health Canada and FDA guidelines
• Sound protocol writing knowledge in a GMP setting, experience with stability protocols an asset.
• Ability to conduct data analysis and create Stability Summary reports
• Strong knowledge of ICH guidelines for stability.

Education, Certification, Licenses & Registrations:

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Biochemistry or related Science from an accredited University.
• 2+ years’ experience in pharmaceutical/life sciences, stability experience an asset

Skills:

Expected high performance behaviors:

• Understanding of analytical laboratory procedures including all relevant pharmaceutical analytical techniques such as chromatography, spectrophotometry, etc.
• Must possess understanding of stability and its purpose with respect to product shelf life.
• Quality minded with ability to work accurately in accordance with established procedures and regulations.
• Must be detail-oriented, meticulous, precise and consistent in laboratory data entries and stability sample information in the stability database.
• Ability to adapt, and flexible, to changes in assignments, to meet department needs and deadlines.
• Excellent communication skills, both verbal and written in English.
• Proficient with MS Office programs
• Have the ability to author technical reports
• Must work well within a team environment.
• Must be able to work in a complex, fast paced environment with an ability to prioritize.
• Safety minded in performance of duties.

Physical Demands:

• May be required to move items weighing up to 25 pounds.
• May be required to sit for long periods of time to perform reviews.
• Individual is required to wear and use appropriate protective equipment in laboratory and operations areas.
• Must be able to work with computers and general laboratory instrumentation.