Quality Assurance Stability Associate
7 months ago
**QUALITY ASSURANCE STABILITY ASSOCIATE**
**Job Location**: River Facility (Bradford, ON)
**Employment Type**: Full-time permanent employment Hybrid (3 Days On Site)
**Division**: Quality Assurance
**Hours**: 40 hours per week
**Salary Range**: $65,000 to $70,000
**A LITTLE ABOUT US**
We are a global cannabis company driven by our passion to help people improve their lives. We have a diverse team who bring their best every day so Aurora can be the cannabis provider of choice for patients and consumers. We love our work, and we especially love our high quality, innovative brands that make up the Aurora family - from Aurora, Aurora Drift, San Rafael ’71 and Whistler.
Our people combined with our collective passion for the industry is what makes Aurora a special place to work and defines what we call our “A-Team”. We are a high-performing team of cannabis experts, innovators, and champions, that work, learn and win together. We think **BIG**, act **BOLD** and execute with **PURPOSE** in all that we do, and will stop at nothing to cultivate the ultimate cannabis experience for our community.
**JOB SUMMARY**
Reporting to the Manager, Quality Control, the Quality Assurance Stability Associate will be responsible for developing and managing on-going product stability and shelf-life programs for Aurora sites within Canada. This role is accountable to comply with requirements in reference to regulations, guidelines, procedures and practives governing GMP and Cannabis. Responsible for strategy development of the stability & shelf-life program.
**MAIN RESPONSIBILITIES**:
- Leads the on-going stability and shelf-life program at all of the Aurora facilities within Canada including design, implementation and roll out; works closely with the Quality leadership team to ensure program meets company objectives and regulatory requirements.
- Collaborates with third party-testing laboratories, operations, regulatory, product development, quality teams etc., and Aurora locations nationally and globally to understand stability testing requirements and needs; leads on-going program development and improvement.
- Leads and writes SOPs and other necessary documentation for enrollment, approval, sampling, storage, inventory tracking, and testing processes.
- Creates, monitors, and trends Key Performance Indicators on the stability and shelf-life program.
- Ensures that stability and shelf-life testing processes align with Quality SOPs, health and safety procedures, and other relevant company policies and procedures.
- Keeps up with current regulations and National and International guidelines on stability and shelf-life as well as Cannabis testing best practices.
- Collaborates with QC Manager, Product Development, Clinical, International and other stakeholders (as needed) on sample enrollment. Oversees on-going stability and shelf-life studies.
- Ensures product samples are enrolled in the stability program by conducting these hands-on tasks onsite at each facility: collect, reserve, prepare and send out samples to the external laboratory as needed.
- Coordinates with third-party laboratories to ensure that samples are received, and results reported in a timely manner.
- Documents analytical results, conducts statistical trending of analytical data for stability and shelf-life evaluation and provides active support in out-of-specification investigations.
- Lead and document out-of-specification results and collaborate with QC Manager, Product Development, International, Clinical Teams, Operations, and Quality Assurance to coordinate timely investigations and outcomes as required.
- Compiles, interpret, and document statistical data to produce reports and recommendations for shelf life and expiry. As well as suitability of potentially aged product.
- Participates in regulatory inspections related to stability and shelf-life; maintains data and reports in audits-ready state and performs data compliance/verification checks.
- Monitors costing and produces reports on costing of the stability and shelf-life program.
- Maintains records of analytical results, sample inventories.
- Where applicable, must adhere to Aurora’s SOPs and comply with Health Canada’s Cannabis Regulations and Good Manufacturing Practice).
- Other duties as required.
**QUALIFICAITONS**:
- Bachelor degree in a scientific discipline such as chemistry, biology, pharmacy, math etc.
- 4 - 5 years year of hands-on work experience in Quality Control or Quality Assurance roles, with preference in Stability testing and data analysis
- Previous experience working in a pharmaceutical, cannabis and/or laboratory environment considered an asset
- Familiarity with ICH, WHO, and food stability requirements
- A team-player who is willing to learn and can work with cross-functional team members
- Excellent time management and organizational skills
- Ability to problem-solve and troubleshoot, particularly when analyzing stability data trends
- Strong knowledg
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