Quality Assurance Associate (Hybrid)

• Perform audits of company facility and studies for compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMEA, etc.);
• Perform inspections of Bioanalytical studies, for compliance with the OECD Principles of Good Laboratory Practices, Study Plans and Standard Operating Procedures (SOPs) at the critical phases of the studies;
• Review Workplans, Study plans, CAPAs, Change Controls/Implementations, SOPs;
• Audit pre-study documentation, in-process activities, end-of-study documentation and study reports;
• Conduct various facility audits, including audits of equipment maintenance, training records, computer validation and vendor qualification;
• Keep Management up to date with findings and follow up on corrective actions;
• Assist in the review, writing and distribution of SOPs, as applicable;
• Assist QA management in hosting sponsor and regulatory audits/inspections;
• Assist QA department in the training of personnel on SOPs and GCPs/GLPs.
• Coordinate and interact with other departments to ensure corporate, departmental and study goals are met.

• BSc in life science, or equivalent.

• 3-5 years QC/QA experience, or related field, preferably including audits of studies in a regulatory environment (GLP preferred);
• Knowledge and understanding of GCP, EMA, OECD, ICH, FDA in relation to Good Laboratory Practice (GLP) and/or GCP/GCLP quality requirements;
• Experience writing and reviewing Standard Operating Procedures (SOPs);
• Clear and concise written and verbal English communication;
• Knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance;
• Various bioanalysis techniques an asset (e.g. Immunoassays, Quantitation, Mass Spectrometry, etc.);
• High level of attention to detail and accuracy, excellent investigative techniques;
• Strong commitment and self-motivated;
• Excellent organizational skills;
• Proven flexibility to adjust to constantly changing priorities, handle multiple tasks, while maintaining quality;
• Ability to work well in a team environment;
• Ability to identify and/or resolve quality issues, in a proactive, diplomatic, flexible and constructive manner;
• Ability to design and implement quality processes.

• Hybrid position based in Montreal: 3-4 days remote, 1-2 days on site;
• Must accept to perform duties (e.g. inspections) in Bio Safety Level (BSL) 1 and 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous viruses such as HIV, HCV, or CMV.

• Competitive Wages;
• Vacation and Personal Days;
• Comprehensive Group Insurance Plans;
• RRSP Contribution with Employer Matching;
• Employee Annual Incentive Plan (EAIP);
• Dialogue Telemedicine Service and Employee Assistance Program (EAP);
• OPUS & Cie Contribution;
• Parking Reimbursement;
• Referral Program;
• Career Advancement Opportunities.

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