Quality Assurance Specialist, Level Iii
3 weeks ago
At Prometic, employees work at saving lives, one role at a time. Located at the heart of the Cité de la Biotech in Laval, Prometic is in full growth-mode now that we are commercializing a treatment approved by the FDA for orphan diseases affecting children. This treatment, made of plasma-derived proteins, allows these children to have a new pathway to hope.
To contribute to this revolutionary and innovative project, we are looking for a **Quality Assurance Specialist.**
The **Quality Assurance Specialist** will contribute to the team’s success by:
Working with the QA Supervisor (Systems) to assist with developing, implementing and executing quality assurance processes and practices that support the manufacture of FDA-regulated biologic products and other related regulatory activities to ensure that performance and quality of products conform to established standards and regulatory requirements.
Supporting the IT corporate team for CSV (Computerized System Validation) activities with all aspects of quality assurance. Performing review and approval of CSV documentations (DS, URS, FS’ Test scripts, IOQ, PQ) related to validation of GMP computerized systems of the site (e.g. Syspro, LIMS, BlueMountain, Smartview, Minitab).
Participating in the management of site Documentation System (drafting, reviewing, and approving Standard Operating Procedures and other GMP controlled documentation), including using MasterControl Documentation Module.
Participating in regulatory and corporate audit preparations and inspections.
**You are the right person for this role because you have**:
A Bachelor in Chemistry, Biochemistry, Biology, Pharmacy, or in a related discipline.
A minimum of seven (7) years knowledge and working experience with all aspects of quality assurance related to a pharmaceutical development organization and a minimum 7 years’ experience working in commercial Quality Systems
Direct relevant experience with biologics or biotechnology derived products.
A thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP), as well as experience with GLPs, GCPS and ICH regulations and guidelines.
**Prometic offers you**:
A fantastic team who strives at doing things in the best possible way;
A casual environment;
A « start-up » culture that values autonomy, innovation and collaboration;
A competitive salary and benefit package
A unique opportunity to change lives through your commitment and contribution.
**Send us your resume right away**
**The usual fine lines**:
Prometic is an equal opportunity employer.
**Job Types**: Full-time, Permanent
**Benefits**:
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
Schedule:
- Day shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Work Location: Hybrid remote in Laval, QC H7V 1B7
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