Quality Assurance Associate

• 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
• Create/format document templates & trackers
• 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 populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.

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