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Quality Assurance, Validation Associate

3 weeks ago

Bradford, Canada Aurora Cannabis Full time

**Quality Assurance, Validation Associate**
**Job location: Remote**
**Employment type: Full Time Permanent**

**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**

Reporting directly to the Director, Corporate Quality, the Manager, Quality Systems is responsible for leading, improving and providing governance to the Quality Systems across organization in alignment with Aurora Cannabis Inc.’s quality strategy to achieve the best service standards and outcomes for patients, consumers, and the company.

**Major Responsibilities / Duties**:

- 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
- Review and approve qualification protocol IOQ of equipment
- Review and approve analytical method validation protocols
- Review and approve User Requirements Specification (URS) for equipment and systems
- Other duties as assigned, including but not limited to: back-up to other departmental roles

**Knowledge, Skills & Abilities**:

- 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.

**Education & Experience**:

- 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

**Why you’ll love working at Aurora**
Our people are at the heart of everything we do here at Aurora, and we take pride in fostering an inclusive space that inspires our team to love where they work From rewarding career opportunities to flexible work env