What are the responsibilities and job description for the Quality Assurance position at Katalyst CRO?
Job Description
The Quality Assurance professional will perform audits and inspections of records, reports, and processes to ensure compliance with regulatory requirements, international standards, and company policies. The role involves reviewing documentation, identifying deviations, supporting client site visits, and assisting with regulatory training and compliance projects.
Responsibilities
The Quality Assurance professional will perform audits and inspections of records, reports, and processes to ensure compliance with regulatory requirements, international standards, and company policies. The role involves reviewing documentation, identifying deviations, supporting client site visits, and assisting with regulatory training and compliance projects.
Responsibilities
- Conduct audits and inspections to verify compliance with regulations, SOPs, and company policies.
- Review and verify accuracy and completeness of SOPs, protocols, batch records, and reports.
- Identify, document, and report deviations from established processes and standards.
- Participate in developing corrective and preventive actions to address audit findings.
- Maintain accurate written records of all audits, inspections, and quality activities.
- Support client site visits and regulatory inspections.
- Assist in providing regulatory training and in scheduling QA audits and inspections.
- Inspect materials and supplies for compliance with specifications.
- Bachelor's degree in Life Sciences or a related field.
- 12 years of experience in a QA role.
- Strong attention to detail and communication skills (verbal and written).
- Proficiency in Microsoft Office (Word, Excel, Access).
- Ability to interpret regulations and apply critical thinking skills.
