QC Validation Specialist - Advanced Recruiting Partners
RTP, NC 27709
About the Job
QC Validation Scientist
Key Responsibilities:
Key Responsibilities:
- Conduct validation activities for QC instruments, including calibration, qualification, and verification.
- Develop, write, and execute validation protocols, including IQ, OQ, and PQ, ensuring they meet regulatory requirements and internal standards.
- Collaborate with cross-functional teams to ensure compliance with industry regulations and quality management systems.
- Document and maintain validation records, ensuring all data is accurate and compliant with regulatory requirements.
- Troubleshoot and resolve any validation-related issues, implementing corrective actions as needed.
- Participate in audits and inspections, providing necessary documentation and support.
- Stay current with industry trends, regulations, and best practices in QC validation.
- Bachelor’s degree in a relevant scientific discipline (e.g., Chemistry, Biology, Engineering).
- Minimum 5 years of experience in QC validation within a contract research or pharmaceutical environment.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA) and quality management systems.
- Proven experience in writing validation protocols and reports.
- Familiarity with QC instruments and validation methodologies.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and organizational abilities.
- Effective communication and interpersonal skills.
Source : Advanced Recruiting Partners
