Clinical Trial Quality Assurance Associate

CTI Clinical Trial and Consulting Services; Covington (KY); Hybrid; USD 40,000 - 60,000; Full time

Benefits offered by this job

Hybrid work option

Health benefits

Paid time off

Job summary

CTI Clinical Trial and Consulting Services is seeking a QA Assistant to support the Quality Management System (QMS) activities, assist sponsor audits, regulatory inspections, and internal system audits, help with CAPA tracking, and ensure SOP formatting and documentation consistency across the organization.

In this role you will coordinate QMS procedures, maintain audit schedules, assist with vendor audits, and collaborate with QA professionals to learn and strengthen quality assurance

Qualifications

• 0-1 years of work experience in QA or related field.
• Basic understanding of GxP Guidelines, including ICH/GCP.
• Excellent verbal and written communication skills.

Responsibilities

• Assist auditors with sponsor audits and regulatory inspections to support the auditing process.
• Support regional testing and maintenance of the Business Continuity Plan.
• Assist in tracking audit findings, deviations and CAPAs within the QA framework.
• Ensure SOPs are consistent in formatting, spelling, and content.

Skills

GxP knowledge

Audit support

Documentation

Communication skills

Education

Bachelor's Degree or equivalent

Tools

QMS

Job description

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

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

What You\'ll Bring:

• 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

About CTI

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. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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