Quality Control Specialist

General Responsibilities:

• Handles tasks under direction and guidance
• Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency and completeness
• Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Inflamax SOPs and study protocols
• Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
• Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists
• As required, follow-up on all QC findings, until a satisfactory resolution has been determined
• Assure documentation review meets or exceeds designated timeline parameters
• Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations
• Ensuring training file and SOP reading is maintained and up to date
• Ensure compliance with appropriate Inflamax SOP’s, GCP and ICH guidelines
• Participate in training sessions
• Participate in training of staff as experience and qualifications permit
• Work in a safe manner that does not endanger yourself or co-workers
• Execute other duties as may be required by the QC Manager and other members of the management team as training and experience allow