Product Analyst, Quality Control

Help bring research to life and drive your career forward with the National Research Council of Canada (NRC), Canada’s largest research and technology organization.

The new Biologics Manufacturing Centre (BMC), at the NRC, will improve the health of and make biomedical innovations more accessible to all Canadians by providing access to additional domestic production capacity for vaccines and biologic products in times of national and global emergencies and for unmet needs. The BMC will be certified as Good Manufacturing Practices (GMP) compliant, will have full end-to-end production capability for mammalian cell-based biologics. This includes a production capacity of approximately 4,000 litres per month, upstream and downstream processing, a quality control lab, filling and secondary packaging, and related logistics management for final products. In the short-term, the BMC’s top priority and focus is to help secure the production of a COVID-19 vaccine for Canadians as quickly as possible, once one is approved by Health Canada. In the longer term, the BMC’s focus will be on providing innovative solutions for the domestic production and supply of novel biologics for the future, while providing Canada with access to a facility that is ready to respond to emergencies, such as a pandemic.

Come and take part in the establishment of the facility and participate in obtaining a drug establishment license from Health Canada. NRC's intention is to transition the site to a different business model over the next few years so the status of positions will be re-evaluated regularly.

The Analyst will contribute to continue the set-up of the QC system (SOPs, forms, detailed work instructions) to support analytical transfer and validation, control of critical consumable and in-process testing.

Once the system will be set-up, he or she will be responsible for:

- Execute analytical methods for protein analysis (intermediate and finished product) and compendia methods finished prodcut.
- Provide support for analytical method verification, validation and transfer.
- Provide support for writing and/or reviewing QC related documentation, ensuring the quality, reliability, accuracy, completeness and consistency according to internal policies and GMP requirements.
- Emission of Certificate of Analysis (CoA) for the semi-finished and finished product.
- OOS/OOT investigation (Out Of Specification and Trends).
- Raw material testing.
- Support to production team.
- Improve the QC activities, when necessary.

**Screening Criteria**:
**Education**:
College diploma (DEC) in science (biochemistry or any scientific related fields).

For information on certificates and diplomas issued abroad, please see Degree equivalency

**Experience**:

- Work experience in the field of pharmaceuticals in biological or chemistry laboratory in a GMP environment
- Experience in cell counting, ELISA and HPLC
- Experience in protein analysis.

**Asset**:

- Experience in Out Of Specification (OOS) investigation.
- Experience in analytical method development.
- Experience in raw material testing
- Experience in documentation management..

**Condition of Employment**:
Secret (II)

**Language Requirements**:
Bilingual Imperative BBB/BBB

Information on language requirements and self-assessment tests

**Assessment Criteria**:
**Technical Competencies**:

- Knowledge of GMP regulation for Quality Control laboratory environment.
- Knowledge of laboratory equipment use and maintenance.
- Knowledge of United States Pharmacopeia and Health Canada regulations.
- Ability to assist in the production of reports, temporary protocols and standard operating procedures (SOP), and to assist in the preparation of SOP and inventories.
- Knowledge in method validation and equipment qualification.

**Behavioural Competencies**:

- Technology support - Teamwork (Level 2)
- Technology support - Conceptual and analytical ability (Level 2)
- Technology support - Client focus (Level 2)
- Technology support - Results orientation (Level 2)

**Competency Profile(s)**:
**Relocation**:
Relocation assistance will be determined in accordance with the NRC's directives.

**Compensation**:
From $49,298 to $69,364 per annum.

In addition, the incumbent will receive the Bilingualism Bonus of $800 per year.

NRC employees enjoy a wide-range of competitive benefits including comprehensive health and dental plans, pension and insurance plans, vacation and other leave entitlements.

**Notes**:

- A pre-qualified list may be established for similar positions for a one year period.
- A flexible schedule and overtime may be required.
- Willingness to occasionnally work on weekend and/or on statutory holiday.
- Assignments and secondments may be considered according to NRC's policies.
- NRC employees enjoy a wide-range of benefits including comprehensive health and dental plans, pension and insurance plans, vacation and other leave entitlements.
- The incumbent must adhere to safe workplace pra