Quality Assurance, Validation Associate

7 days ago

Bradford, Canada Aurora Cannabis Full time

**Quality Assurance Validation Associate**

**Job location: Bradford, ON**
**Employment type: Full Time Employment**

**Hours: 40 Hours per week**

**A little about us**

Hi, we’re Aurora Cannabis, and we’re so excited to meet you

We’re 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**

Are you a cannabis enthusiast with an energetic spirit? Are you looking to work with a fun group of people? If so, we would love to meet you

We’re looking for an ambitious and hard-working professional to join our Quality Assurance team in the role of **Quality Assurance Validation Associate**

**As a **Quality Assurance Validation Associate,** you will.**
- Promote positive safety culture through participation, and adherence to, HSE programs
- Promote positive working relationships with all departments
- Act as an ambassador for regulatory and process compliance
- Maintain knowledge of applicable standards, regulatory requirements, and statistical methods
- Liaise supports and stakeholders to ensure qualification/validation expectations met
- Liaise with external supports or vendors, where appropriate, for added technical guidance
- Maintain and continuously improve validations program
- Develop equipment performance qualification, and process validation protocols
- Develop cleaning validation protocols and risk assessments
- Provide training specific to each planned protocol prior to execution
- Assist in execution of qualification/validation protocols
- Identify deviations from established processes or equipment standards and provide recommendations to resolve; follow-up with owner to ensure recommendations are sufficiently addressed
- Write and maintain SOPs related to validation or performance qualification
- Maintain requalification and revalidation expectations, or exemption justification
- Ensure requalification and revalidations are complete where required
- Prepare detailed reports or design statements, based on result of qualification/validation
- Maintain overview of equipment set-points and equipment process set-points
- Complete validation impact assessments as assigned
- Prepare validation training, and provide training to additional supports as required
- Create flow diagrams and value stream mapping where required
- Participate in self-inspection
- Other duties as assigned, including but not limited to: back-up to other departmental roles

**You would be the best fit for this role if you have**
- Organized, systems-oriented thinker with a strong understanding of continuous improvement
- Previous experience in process design, flow mapping, writing, and conducting process validations and equipment performance qualifications.
- Demonstrated ability in project management and project management tools.
- Strong computer skills (Word, Excel, PowerPoint, Visio, etc.).
- Exceptional listening, communication, analytical and problem-solving skills.****:

- Ability to handle multiple priorities and a dynamic changing environment.
- Able to bring innovative solutions to process and equipment design and flow mapping.
- Flexible, adaptable, and previous experience in a fast-paced environment.
- Able to travel between Aurora locations.
- Degree or diploma in a relevant field, such as: Pharmaceuticals, Biotechnology, Engineering, Manufacturing, Quality Assurance, Quality Control, Laboratory Sciences Certification as a Quality Engineer, Process Analysis, Continuous Process Improvement, LEAN or Six Sigma considered an asset.
- 1 to 3 years of experience in Validation, with experience in equipment qualification, process, and cleaning validation
- 2 to 5 years of experience of working in Production/Quality department in pharmaceutical manufacturing environment
- Familiarity with regulatory requirements with respect to validation and qualification activities in pharmaceutical industry
- Certification in Project Management, while not required is considered an asset
- Knowledge of GMP, and Health Canada regulations.

**Bonus points if you have**
- Strong attention to detail
- Strong organizational skills and the ability to achieve objectives, as well as prioritize tasks.
- Strong communication and problem-solving skills.
- Intermediate to excellent

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