QA Associate II (Laval)
Work schedulePermanent, full time
Start dateAs soon as possible
The Quality Assurance (QA) Associate II reports directly to the Director of Quality Assurance. He/she is responsible to support management in the monitoring and maintenance of effective quality systems and to ensure that GxP requirements, applicable guidelines and internal quality systems are respected at the Nexelis Laval site.
- Maintain document control systems and implement the appropriate quality-related policies and procedures required for regulatory compliance;
- Review policies and procedures for regulatory compliance and consistency, as well as policies for business and technical practices, and convey those throughout the Nexelis Laval site;
- Undertake and assist with a variety of GxP audits, such facility, in-lab and study audits. Study audits, include review / audit of study-specific plans and any amendments, raw data, tabulated data, reports, contributing reports, equipment and computerized system validation deliverables, etc.;
- Assist management to execute vendor and subcontractor audits;
- Support management in the preparation and hosting of client audits;
- Support management in certification/accreditation process and maintaining certifications/accreditations, when required;
- Participate in root-cause analysis and other problem solving/investigation activities to ensure that effective corrective/preventive actions are implemented and processes are improved;
- Assist management in developing and providing applicable regulatory/quality-related trainings.
Experience and Qualifications
- Minimum of three (3) to five (5) years’ experience in Quality Assurance, Quality Control and/or Quality Operations in a regulated environment, preferably in a pharmaceutical/CRO setting;
- Good knowledge of regulatory requirements including GCP (Good Clinical Practices) and GLP (Good Laboratory Practices);
- Strong written and verbal communication, analytical, problem solving and conflict resolution skills;
- Autonomous, detailed oriented and excellent interpersonal skills;
- Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment;
- Good knowledge of immunology testing and laboratory activities within a regulated environment;
- Fluently bilingual in English and French (both oral and written);
- Excellent computer skills in the Microsoft Office Suite.
Bachelor’s degree in a scientific discipline, preferably in biology or biochemistry, or equivalent