Quality Assurance Specialist, Sterile Operations

2 weeks ago

Montréal, Canada Centre de production de produits biologiques Inc Full time

The Biologics Manufacturing Center ( BMC ) Inc. is a new biomanufacturing facility created in response to the pandemic. A not-for-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC helps support projects of public interest, actively contributes to the overall growth and resilience of the Canadian life sciences industry, and fosters industry development and innovation through Canadian production. Backed by a committed and innovative team of employees, the BMC fosters a culture of agility and transparency, with a collaborative, results-oriented approach.

We are looking for a **Specialist, Quality Assurance - Operations and Sterility** who will be responsible for ensuring product quality and continuous process improvement by leading risk prevention initiatives and identifying corrective and preventive measures. In addition, the Specialist ensures that quality events and complaints related to the activities of the BMC are properly documented and investigated.

Reporting to the Quality Assurance Supervisor, the **Specialist, Quality Assurance - Operations and Sterility** will be responsible for:

- Conduct quality event investigations in collaboration with the relevant department managers (e.g. Chief, Supervisor, Technician and Expert) to determine root causes with a view to continuous improvement, using structured analysis tools (e.g. 5 Whys, Ishikawa cause-and-effect diagram, 6M, DMAIC approach).
- Propose appropriate corrective and preventive actions (CAPA) to reduce recurrences, improve processes and measure their effectiveness.
- Review and approve investigation reports from various departments (events and minor deviations).
- Write detailed investigation reports (major/critical deviations and customer complaints) and submit them for approval to the department manager, quality assurance manager and customer in a timely manner to meet established procedures and delivery deadlines.
- Lead initiatives focused on risk prevention (CAPA effectiveness verification, quality-oriented GEMBA walk, etc.) and continuous process improvement.
- Act as a resource person and coach from a quality point of view for all those involved in sterility, contamination prevention, the investigation process and, more broadly, for all employees involved in GMP-related activities.
- Monitor departmental performance by issuing and tracking key performance indicators (KPIs).
- Identify opportunities for continuous improvement by conducting trend analyses of quality events.

**Does this position match your career aspirations? We would like to receive your CV if**:

- You have a bachelor's degree in a scientific discipline (biochemistry, microbiology, engineering).
- You have at least 5 years' experience in quality assurance in the pharmaceutical industry, including at least 3 years in the manufacture of sterile products.
- You have in-depth knowledge of investigation methods (6m, Ishikawa, 5 whys, etc.).
- You are comfortable using quality management software.
- You are able to express yourself in French.
- You are able to write investigations and reports in English for our international customers.
- You live in the province of Quebec.

**The BMC, an employer offering what's important to you**
- A flexible schedule and work mode hybrid
- A culture of transparency, notably with our monthly corporate meetings
- A respectful and friendly work environment
- A new building with state-of-the-art equipment
- A competitive salary commensurate with your skills
- An attractive vacation and leave program
- A group RRSP with a generous contribution from the BMC
- A comprehensive insurance plan including telemedicine
- An opportunity to participate in our various life committees (social club, employee committee, OHS committee, etc.)
- A host of activities throughout the year to socialize with your colleagues, recognize team successes and improve your knowledge.
- Free on-site parking.

**The BMC, an organization like no other**
- Our team is made up of talented, committed individuals with diverse backgrounds.
- We aim to develop, share and transmit knowledge
- Our NPO status enables us to reinvest every dollar of profit back into the organization
- Our human scale empowers all our employees to participate in driving the company forward
- Our economic positioning is unique in our industry
- Our social mission is extraordinary

**The BMC, a key player in Canadian biotech production**

The BMC is a new facility in the heart of Montreal, completed in June 2021. It supports the growth of the country's biologics production capacity, ensuring that vaccines and other related products can be manufactured safely, right here at home. Thanks to its state-of-the-art facilities and the knowledge of its team, the BMC can produce biopharmaceutical products such as viral vector, protein subunit and virus-like particle vaccines, as well as other biological products. It is a key player in Canada's ability to respond rapidl

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