Job: CRO QA Associate (contract to hire), PharmaSys, Inc., Cary, NC
CRO QA Associate (contract to hire)
Cary, NC 27513 United States
This is a contract position. This may be a contract to hire position based on client needs.
- Manage training curriculum and ensure that all corporate training records are up-to-date
- Oversee document management system and ensure that policies, procedures and work instructions are appropriate and up-to-date
- Participate in the development Corrective and Preventive Action (CAPA) plans and contribute to resolution of findings.
- Plan and conduct quality assurance (QA) audits (including document and process audits) per procedure, as needed
- Develop quality-related documentation for client projects, including SOPs, work practices, forms, training materials, etc., under the direct supervision of the Project Lead
- Assist with project management activities associated with quality projects, including maintenance of project information
- Review and organize computer validation documentation and ensure compliance with associated regulations and guidance including 21 CFR Part 11.
- Observe and adhere to applicable regulatory and legal requirements, including participation in impact assessments for sponsors for any regulatory updates
- Perform quality review of clinical study data and procedures
- Interact directly and with internal groups and sponsors. Demonstrate strong client interaction skills
- Participate in company and departmental process improvement and recommend suggestions to improve efficiencies
- Represent self and company in a professional manner and in line with core company values
- Practice excellent internal and external customer service, communication, and teamwork
- Support objectives and improvement efforts within department and organizationally
- Comply with all applicable policies, procedures, and training requirements
- Bachelor’s degree in biomedical, nursing or related life science discipline required
- 2 years of related experience or relevant pharmaceutical, health authority and/or CRO experience
- Prior experience in a Quality Assurance department required
- Understanding of data management and computer system validation methodologies
- Understanding of GxP training requirements
- Provides oversight and development of Quality Management Systems (QMS)
- Understanding of US and EU GCP, GxP and 21 CFR Part 11, regulations and guidelines
- Understanding of scientific, medical, and/ or clinical data
- Excellent, demonstrated verbal and written communication skills
- Proficient with MS Office applications
- Excellent organizational and communication skills and detail-oriented
Only qualified applicants meeting the minimum requirements will be considered.
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