Quality Assurance Associate

**Quality Assurance Associate**
**Summary**
Reporting to the Director of Quality Assurance, the Quality Assurance (QA) Associate is responsible for conducting and reporting quality assurance audits and reviews as scheduled. The QA Associate supports the QA department in assessing compliance of clinical and non-clinical studies with applicable regulations, guidelines, study protocols, study plans and company SOPs.
**Responsibilities**
- 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.

**Education**
- BSc in life science, or equivalent.

**Main Requirements**
- 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.

**Working Conditions**
- 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.

**Benefits**
We offer a wide range of benefits including:

- Competitive Wages;
- Vacation and Personal Days;
- Dialogue Telemedicine Service and Employee Assistance Program (EAP);
- OPUS & Cie Contribution;
- Parking reimbursement;
- Referral Program.

**About CellCarta**
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.
Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world
**Join us as we make an impact on patient therapy**:
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