Quality Control Coordinator - Data Review

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, result-oriented approach.

We are looking for a Quality Control Coordinator - Data Review who will contribute to the quality of analytical data by ensuring its accuracy, integrity and compliance. Working closely with Analysts, the person will review analytical data and associated documentation, support the application of Good Manufacturing Practices (GMP) and contribute to the issuance of internal Certificates of Analysis.

The Quality Control Coordinator - Data Review will have the following responsibilities:

• Coordinate and perform the review of analytical data, source data, logs and associated documentation to ensure accuracy, integrity and compliance with GMP, Good Documentation Practices (GDP) and ALCOA+ principles;
• Identify errors, discrepancies and potential compliance issues during the review process and coordinate required corrections with Quality Control analysts;
• Verify the completeness and consistency of analytical records, including the alignment of data entered in laboratory electronic systems with source data and associated documentation;
• Coordinate data review activities based on laboratory priorities and timelines to ensure records are processed within required timeframes;
• Prepare and review internal Certificates of Analysis to ensure accuracy and compliance;
• Act as a resource for analysts on GMP, GDP and data integrity requirements;
• Manage controlled laboratory forms, including access, availability and distribution.

This role matches your career aspirations? We want to receive your resume if:

• You hold at least a college diploma (DEC) in a relevant field.
• You have at least 2 years of experience in data review within a GMP environment.
  • A combination of relevant education and experience may be considered.
• You have direct experience with chemical and/or chromatographic analytical techniques.
• You are fluent in French.
• You are able to read and write technical documentation in English.
• You have intermediate proficiency in Excel.

The BMC, an employer offering what matters to you

• A flexible schedule
• 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 disseminate knowledge.
• Our non-profit status enables us to reinvest every dollar of profit back into the organization.
• Our people-focused size allows all employees to contribute to the organization’s growth and evolution.
• Our economic positioning is unique within 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 rapidly to future national and global health emergencies.