QA Specialist

Are you passionate about product quality? Are you driven by using your skills to solve problems for users? Are you interested in being part of the team that helps improve quality.

We are looking for a creative problem solvers to assure the quality of our existing products and create assured quality for our new ones.

Quality Assurance is vital to the success of our company

Under supervision of the CVT QA /Services Director, you will be responsible to coordinate, developping and implementing Quality/ validation processes to ensure products and services meet with appropriate regulatory agency requirements, internal company standards and current industry practices. Coordinates and reviews quality /validation area processes and procedures, making recommendations for changes and/or improvements in conjunction with our regulatory service/instrumentations/R&D teams.

You will be tasked with:

- Write /execute / reviews (protocol generation, execution, and final package preparation) process validation/quality activities related to the implementation of process changes and new processes while exercising judgment with broadly defined procedures and practices to establish approval criteria, identify and implement solutions to meet CVT and Regulatory Agency Requirements.
- Co-ordination the mapping /Thermal equipment’s/ system validation project expectations with CVT Pharma clients
- Identifies, implements improvements and reviews to the QA/QC Process (Policies, SOPs, and technical Quality documentation to support regulatory /instrumentations / R&D practices) to meet CVT and Regulatory Agency requirements
- Create and execute testing plans and procedures according to the most appropriate methodology, report anomalies and follow their corrections with the R&D team.
- Create and prioritize bug reports with clear reproduction steps
- Conduct the team meetings and provide employee training on compliance related topics, policies and or procedures

You will have the following:

- College diploma in science, industrial pharmacy or related discipline
- Min 3 years of prior experience in pharmaceutical/biotechnology technical operations experience ( Quality Assurance/Quality control, Validation)
- Bilingual ( French/English)
- Knwledge of GMP's guidelines, and process validation / QC
- Proficient in Microsoft Word and Excel
- Excellent organizational and prioritization skills and methodical attention to detail
- Able to travel without required to quarantine
- Driver license

Why work for us:

- Competitive salary
- Promote career development
- Collective group medical insurance coverage ( 60% paid by employer)
- RRSP/DPSP match up to a maximum contribution of 6%
- 6 sick days
- Generous vacation above employment standards
- Teledoctor
- Employee aid program
- Great team spirit

**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
- Tuition reimbursement
- Vision care

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Anjou, QC: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Knowledge of GMP's guidelines, and process validation / QC

**Education**:

- AEC / DEP or Skilled Trade Certificate (preferred)

**Experience**:

- quality assurance: 3 years (preferred)
- Pharmaceutical or biotechnology: 3 years (preferred)

**Language**:

- English (preferred)
- French (preferred)