Quality Assurance Associate

• 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.

• 1-5 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.

• Onsite/hybrid position in Montreal;
• One year contract, 37.5hrs per week;
• 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;
• Dialogue Telemedicine Service and Employee Assistance Program (EAP);
• OPUS & Cie Contribution;
• Parking reimbursement;
• Referral Program.

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “CellCarta”). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.

CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact [email protected].