Clinical Trial Quality Assurance Associate

What You ll Do:

• Assist Auditors with Sponsor audits and regulatory authority inspections to facilitate the auditing & inspection process
• Manage and initiate regional testing for the annual update of the Business Continuity Plan
• Assist in tracking audit findings, deviations and CAPAS identified in a Quality Assurance Audit
• Quality control of Standard Operating Procedures (SOPs) ensuring consistency in formatting, spelling, etc.
• Manage the distribution process for company SOPs
• Recommend changes to current processes to provide more effective use of the LMS and take the lead to implement such changes
• Maintain quality records per SOPs
• Work closely with Auditors to learn and enhance Quality Assurance responsibilities
• Assist with maintaining audit schedules and tracking of deliverables
• Assist QA Auditors with conducting Vendor Audits, Internal System Audits and Computerized Systems validation, gaining experience to begin completing these tasks independently
• Assist in coordination of all activities related to the QMS, including but not limited to co-administration, routine review of quality control documentation, and development and execution of system user acceptance testing documentation
• Assist with the creation of procedures and work instructions/job aids relating to the QMS ensuring consistency and quality of content
• Assist QMS Document owners/users with entry of data into QMS
• Assists management with timely and appropriate follow up of deviations and CAPAs in the QMS in accordance with internal policies/SOPs
• Assist with completion of RFIs related to Quality Management Systems
• International region-specific functions

• Assist Auditors with Sponsor audits and regulatory authority inspections to facilitate the auditing & inspection process
• Manage and initiate regional testing for the annual update of the Business Continuity Plan
• Assist in tracking audit findings, deviations and CAPAS identified in a Quality Assurance Audit
• Quality control of Standard Operating Procedures (SOPs) ensuring consistency in formatting, spelling, etc.
• Manage the distribution process for company SOPs
• Recommend changes to current processes to provide more effective use of the LMS and take the lead to implement such changes
• Maintain quality records per SOPs
• Work closely with Auditors to learn and enhance Quality Assurance responsibilities
• Assist with maintaining audit schedules and tracking of deliverables
• Assist QA Auditors with conducting Vendor Audits, Internal System Audits and Computerized Systems validation, gaining experience to begin completing these tasks independently
• Assist in coordination of all activities related to the QMS, including but not limited to co-administration, routine review of quality control documentation, and development and execution of system user acceptance testing documentation
• Assist with the creation of procedures and work instructions/job aids relating to the QMS ensuring consistency and quality of content
• Assist QMS Document owners/users with entry of data into QMS
• Assists management with timely and appropriate follow up of deviations and CAPAs in the QMS in accordance with internal policies/SOPs
• Assist with completion of RFIs related to Quality Management Systems
• International region-specific functions

• Bachelor s Degree or equivalent combination of education and experience
• 0-1 years of work experience
• Basic understanding of GxP Guidelines, namely ICH/GCP Guidelines and relevant country specific regulations
• Excellent verbal and written communication skills

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient…