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Capa Coordinator Jobs
Company | Advanced Clinical |
Address | Kent County, DE, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-04 |
Posted at | 9 months ago |
Overview
- This is a remote position that be worked from home anywhere in the United States or Europe***
- Lead the Noncompliances and CAPAs through the QMS workflow
- For ongoing periodic review, data inquiries, and status updates
- Responsible for leading Root Cause Analysis, corrective and preventative action (CAPA)
- Ensure that investigation/CAPA documentation is compliant with GxP, industry
- Work with SMEs to develop appropriate effectiveness checks, as applicable
- Perform other duties as assigned
- Monitors and analyzes CAPA metrics and program trend analysis
- Ensure investigations are approved by correct personnel and departments in a timely manner
- Provide support in regular metrics reporting for Noncompliances and CAPAs
- Provide training on the Noncompliance, CAPA and effectiveness check process/requirements to company staff
- Lead the overall administration, tracking and management of Noncompliances and CAPAs at Advanced Clinical
- Standards, company policy/procedure requirements.
- Support subject matter experts (SMEs in conducting root cause analysis and developing CAPA plans using common industry techniques
- Review Noncompliances to determine if an investigation or CAPA is necessary and recommends effectiveness plans.
- Provide support to Compliance and Quality Management and Operations Quality teams
- Must be able to work independently, manage multiple tasks, and meet defined deadlines.
- Experience: Have previous experience working in an electronic Quality Management System such as Veeva Vault; Previous experience working in organizations regulated by Good Clinical Practices (GCPs); minimum 2 years performing quality tasks, to include noncompliance and CAPA activities
- Establishes effective relationships with customers to understand and meet their needs.
- Education: Bachelor’s or equivalent degree in a relevant field of study (including but not limited to Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is preferred or equivalent years of experience
- Certification: Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)
- Strong oral and written communication skills with the ability to create concise technical documentation.
- Must be a team collaborator, have exceptional organizational and time management skills, and be proficient with applicable software systems.
- Training: Applicable quality assurance, regulatory, or clinical research-related training preferred
- Ensures customer service standards are met.
- Questions currently accepted ways of doing things. Generates alternatives before settling on a solution.
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