Quality Control

2 weeks ago

Montréal, Canada National Research Council Canada Full time

Join us in making biomedical innovations more accessible to Canadians. The new Biologics Manufacturing Centre is helping build Canada’s capacity to produce, access and supply vaccines and other biologics to advance Canada’s biomanufacturing sector and respond to public health emergencies.

The QC Data and Documentation Review Officer will be responsible to assure and coordinate the various source data and associated documentation review for accuracy ,GMP and GDP compliance by working closely with the QC team to facilitate data or documentation corrections with QC Analysts ensuring all analytical records are complete, appropriate references are made and any potential compliance issues (i.e. discrepancies) which could affect product quality are reported. They will work within a flexible, dynamic and agile team and play a key role in supporting QC operations to make sure the department is compliant in regards to data and documentation.

The QC Data and Documentation Review Officer will also participate in the writing, revision and formatting of various documents such as SOPs, analytical methods, work instructions, validation and investigation reports while proactively contributing to Quality Control activities from a GMP documentation perspective by proposing and highlighting improvements to documents when necessary.

Responsibilities include but are not limited to:

- Assures and coordinates the review of analytical data (source data and associated documentation) according to GDP and ALCOA+ principles to ensure accuracy and GMP conformance;
- Helps to consolidate and reconcile documents and all associated supporting records pertaining to quality control activities.
- Facilitates data and documentation corrections to ensure all records are complete and appropriate references are made;
- Works closely with QC Personnel to ensure documents and data are reviewed within the allowed timeframe.
- Performs data review within the Laboratory Inventory Management System (LIMS) of the QC Laboratory.
- Highlights any potential compliance issues encountered during data review which could affect product quality.
- Reviews analytical data entry in the Laboratory Inventory Management System (LIMS) against source data and associated documentation
- Participates in the writing, revision and continuous improvement of departmental documents by suggesting modifications to procedures according to GMP, GDP and regulatory requirements;
- Initiates and reviews procedures and documents, both in French and English, in collaboration with other members of the QC department.

The NRC will soon be transitioning Biologics Manufacturing Centre (including employees and operations) to a not-for-profit corporation structure (outside the Government of Canada). As a result, this is a term employment opportunity with the NRC until March 31, 2023, with the expectation that it transitions under the new organization on a permanent basis after this date.

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