Stability Coordinator

**_Nature of the Position:_**

The Stability Coordinator is responsible for the administration of the day to day aspects of Vita’s stability program for Natural Health Product and Over the Counter Drug Products.

This role will review stability requirements including internal protocols design, to test the stability of IVC Vita Health products.

The Stability Coordinator will author, review and edit stability protocols and stability reports, managed stability sample enrollment and draws collect collate and analyze stability data generated during stability studies in support of product stability profiles.

**_Responsibilities:_**
- Designing stability studies, authors protocols, special studies and summary reports.
- Identify, assemble and enroll product lots into the stability program in order to meet compliance and regulatory requirements, creating and printing labels for inventory tracking and reconciliation.
- Monitor the production/packaging schedule, issue stability sampling forms, and receives the samples from the production department.
- Identifying inventory required to satisfy annual stability commitments; maintaining a master stability inventory list in an audit ready state as studies are added or removed. Includes monthly reporting of captures, set-ups, special studies and year-to-date progression.
- Store and remove samples from stability chambers for testing at intervals designated in the stability protocols and provide to QC.
- Ensures stability sample inventory is up to date and correct according to program guidelines.
- Maintains stability chambers and areas within applicable regulatory and company standards and documentation requirements.
- Compilation of testing data for all stability samples.
- Participate in stability OOS (out of spec) investigations, assesses the impact on current stability studies and product shelf life.
- Reviews and examines stability data on a continual basis, using statistical measures to examine trends throughout shelf life
- Responsible for fulfilling the requirements: for Vita’s SOPs that relate to: stability; handling of the product; personnel hygiene; safety and all other pertinent SOPs impacting the Stability unit
- Responsible for SLIM usage to: assist in the setup studies and tests using established protocols; browse and print studies; use SLIM calendar to pull and request samples; Basic data entry using stability management (SLIM) program.
- Responsible for supporting Stability unit: in all duties, as assigned, related to stability as directed by the Stability Supervisor or management.
- Performs data integrity review of stability study data and documents.

**_Qualifications: 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.

**_Qualifications: _**_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.

**Salary**: $20.00-$23.00 per hour

**Benefits**:

- Casual dress
- Company events
- Company pension
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match