QA Auditor
2 weeks ago
General Responsibilities:
- Prepare and conduct routine audits of Clinical and Scientific Affairs projects conducted at the site as scheduled
- Review protocols, informed consent forms, source document templates/logs and other project-specific documentation not otherwise reviewed formally in an audit
- Assist in the preparation and conduct of routine process and system audits, as well as audits of validation and/or qualification of computerized systems and facilities
- Keep QA Management up to date with findings and follow up on corrective actions
- Analyze and evaluate available data and prepare written audit reports of findings and observations
- Perform adequate and timely follow-ups of audits, and issue Quality Assurance statements/certificates for audits conducted
- Create Quality Plans, Audit Plans, Audit Checklists for assigned projects
- Assist the site and QA management in the identification of quality process improvement opportunities and in the development of new processes, documentation and other tools
- Work with the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures as required
- Ensure compliance with appropriate Inflamax Research SOP’s, GCP (&/ or GLP if applicable) and ICH guidelines
- Execute other duties as may be required by QA Management and other members of the Inflamax Research Management team as training and experience allow
Qualifications:
- Minimum Bachelor of Arts of Science Degree in a related field or sufficient equivalent relevant training and experience
- Relevant experience in quality review (QC/audit) of documents and processes in various phases of clinical trials and/or validation of bioanalyticial methods and bioanalysis is preferred
- Practical knowledge of, and current with regulatory requirements pertaining to clinical &/or pre-clinical research (HPFB, FDA, EMA, MHRA, GxP)
- Attention to detail and the ability to spot inconsistencies a must
- Ability to understand and follow basic scientific research protocol and procedure
- Well-developed analytical and problem solving skills, and have the ability to analyze and interpret scientific data
Schedule:
- 8 hour shift
Ability to commute/relocate:
- Mississauga, ON: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (preferred)
**Experience**:
- QC/Auditing: 1 year (preferred)
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