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Quality Assurance Engineer
2 months ago
Job Summary:
TechOne Staffing is seeking a highly skilled Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our equipment, facilities, and processes meet the highest standards of validation.
Key Responsibilities:
- Design and execute validation protocols to ensure compliance with regulatory standards.
- Develop and maintain validation documentation, including protocols, reports, and databases.
- Collaborate with cross-functional teams to plan and execute validation activities.
- Resolve technical issues and troubleshoot validation problems.
- Manage and track validation projects, including timelines and deliverables.
- Provide training and support to team members on validation procedures and best practices.
- Stay up-to-date with regulatory requirements and industry standards.
Requirements:
- Strong understanding of FDA, cGMP, GAMP, and related regulatory standards.
- Expertise in creating and executing validation protocols (IQ, OQ, PQ, CSV, etc.).
- Ability to troubleshoot and resolve technical issues during validation.
- Effective communication and coordination with internal teams and external suppliers.
- Proficiency in managing validation documents, databases, and SOPs.
What We Offer:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
Language: English (en-US)