Clinical Trial Quality Assurance Associate
New
C
CTI Clinical Trial and Consulting ServicesClinical Research
United StatesFull-TimeEntry
Salary not disclosed
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Job Details
- Experience
- 0-1 years of work experience
- Required Skills
- GCPComplianceQuality Assurance
Requirements
- Bachelor’s Degree or equivalent combination of education and experience
- 0-1 years of work experience
- Basic understanding of GxP Guidelines
- Knowledge of ICH/GCP Guidelines
- Understanding of relevant country specific regulations
- Excellent verbal and written communication skills
Responsibilities
- 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
- Assist QA Auditors with conducting Vendor Audits, Internal System Audits and Computerized Systems validation
- Assist in coordination of all activities related to the QMS
- Assist management with timely and appropriate follow up of deviations and CAPAs
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