Quality Assurance Analyst

**WE’RE HIRING**

Let’s help you launch your career with Alberta Veterinary Laboratories (“AVL/Solvet”) We are looking for an energetic and dedicated **Quality Assurance Analyst** to join our team **on-site** in our Calgary facility working 40 hours/week (Monday - Friday).

**THE ROLE**

Reporting to the QA Manager, the QA Analyst is responsible for the daily QA activities, reviewing all documentation for Production QA needs. Working closely with members of the operations and production teams to drive performance through providing exceptional attention to detail and compliance support.

The objective of this role is to support business operations and ensure the highest quality is maintained in our processes and products. As the main contact for production needs, this role is integral for monitoring quality and supporting operations to ensure standard compliance needs are met.

**DAY-TO-DAY**

- Implementation and maintenance of quality management system in a Health Canada-certified GMP (Good Manufacturing Practice) pharmaceutical facility.
- Implementation and understanding of SOP’s addressing sanitation, pest control, document control, preventative-centered quality assurance, results-based quality control, material management, product recall and production practices, etc.
- Review and modification of SOP’s addressing sanitation, document control, preventative-centered quality assurance, results-based quality control, material management and production practices, etc.
- Write drafts of stability studies protocols
- Initiate and monitor stability program for Finished drug products and APIs.
- Participate in preparing Annual Product Quality review (APQR).
- Participate in Risk Assessment for different quality and regulatory events.
- Participate in OOS, Deviation and CAPA investigations and validations as required.
- Perform internal and House Keeping audits to ensure GMP is maintained throughout the facility
- Inspect and review batch manufacturing records, verify reconciliation of batch inputs, batch yields and release / rejection of finished products
- Working daily in the ERP system to release finished batches and make inventory adjustments.
- Ensure all analytical results and documentation are of high quality, generated contemporaneously, comply with GMP regulations and comply with company data governance policy
- Oversee and participate all incident investigations including initiation, root cause analysis, corrective and preventative actions and effectiveness follow-up.
- Monitor Change Control to track progress and resolve product issues
- Quality checks on raw materials and finished products including problem solving based on findings and decision-making
- Issuing, filing, review of records and logbooks and required follow-up
- Other duties as required.

**IDEAL FIT**

Education & Experience

- Minimum Bachelor of Science with Major in Chemistry, Biochemistry, Chemical Engineering or related field.
- 3-7 years experience working in a Quality environment in Quality Control and/or Quality Assurance, with preference to pharmaceutical or food industries.
- Understands the meaning of and able to implement Good Manufacturing Practices in the pharmaceutical industry
- Understands the content of and/or how the following should be implemented: Policies, Standard Operating Procedures (SOPs), Work Instructions
- Experience with computer programs, databases and electronic data records
- Understanding of GMP, international pharmacopoeia and ICH guidelines
- Experience with instrument software programs (Empower, etc.)

Skills and Attributes

- Great interpersonal and communication skills (professional level of English required)
- Reliable, punctual and thrives as part of a busy team
- Highly detail-oriented, hands-on, resourceful, and proactive in preventing and solving problems
- Proven organizational and time-management skills with the ability to prioritize to meet deadlines
- Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
- Curiosity driven with the motivation and ability to troubleshoot challenging processes and solve complex technical problems
- Able to work both independently with mínimal oversight and as an integral part of the team mentoring junior team members to build their confidence and analysis skills
- Comfortable with multi-tasking and adaptable to changing priorities within a team-oriented entrepreneurial environment, including being an alternate for QA if requested
- Consistently demonstrates initiative and willingness to go above and beyond
- Able to remain calm under pressure

**REQUIREMENTS**

- Criminal Record Check
- Medical Clearance

**WORKING CONDITIONS**

- **On-site** in SE Calgary
- GMP compliant facility
- 40 hours/week (Monday - Friday)
- Occasional interaction with chemicals and hazardous materials

**WHAT’S IN IT FOR YOU**

We are committed to keeping our team healthy and motivated, so they can do the best work of their lives.