Quality Assurance Specialist

2 weeks ago

Laval, Canada Prometic Full time

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 have commercialized a treatment recently approved by the FDA for orphan diseases affecting children and adults. This treatment, made of plasma-derived proteins, will allow 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:
Participate in the evaluation and approval process that supports the Manufacturing of FDA regulated biologics and ensure that product performance and quality are in compliance with established standards and regulatory requirements.

Be responsible for QA activities related to manufacturing through the evaluation and approval of deviations, investigations and CAPAs related to maintenance and engineering operations in accordance with cGMP requirements.

Be responsible for the complete review and approval of batch records and associated documentation in support of batch final release; responsible for the intermediate and final product release.

Provide QA oversight on daily manufacturing activities, verify manufacturing records as they are completed and immediately address and resolve any deficiencies while in the production zones.

Provide QA oversight of product storage and plasma dispensing.

Participate in the management of site Documentation System (drafting, reviewing, and approving Standard Operating Procedures and other GMP controlled documentation), including using Master Control Documentation Module;
Be responsible for the review and issuance of Master Batch Records

**You are the right person for this role because you have**:
A Bachelor’s in chemistry, Biochemistry, Biology, Pharmacy, or in a related discipline.

Six (6) years of experience in a similar role in the pharmaceutical industry 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.

Experience in various commercial Quality Systems (min 2-3 years).

A sound command of French and English both written and oral.

You have the ability to analyze complex issues, work independently and the flexibility to meet changing business and stakeholder needs.

**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.

Additional pay:

- Bonus pay

**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

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