Job Title:
Principal QA Validation Specialist
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Summary:
A highly experienced Principal QA Validation Specialist is required to provide technical leadership and mentorship for qualification activities and data integrity initiatives in the field of small manufacturing and laboratory equipment.
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Key Responsibilities:
* Equipment Knowledge: Strong understanding of equipment used for QC analysis and operations, including HPLC/UPLC, TOC analyser, FTIR, and microscopes.
* Qualification Process: Supervise end-to-end qualification process to ensure each piece of equipment fits for intended use and contributes to 365 inspection readiness program.
* Quality Culture: Foster and implement a quality culture and company manufacturing standards, policies, and procedures.
* Data Integrity: Experience with site change control, risk management, and data integrity initiatives/programs.
* Regulatory Audits: Previous experience as a SME in highly regulated environments (pharma, biotech, medical devices) in internal and external regulatory audits.
* Qualification Activities: Schedule, execute, review, and approve qualification activities.
* Change Controls: Assess executed change controls and deviations for impact to qualified state, conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
* Troubleshooting: Investigate and troubleshoot problems, determine solutions or recommendations for changes and/or improvements.
* Documentation: Review, edit, and approve deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports, and other documentation.
* Collaboration: Coordinate with departments and contractors/vendors to complete validation tasks and resolve issues.
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About You:
* Expert Knowledge: EU annex 11 and FDA 21 CFR Part 11.
* Data Integrity: Strong knowledge of Data Integrity.
* Time Management: Ability to prioritize and handle multiple tasks simultaneously.
* Project Management: Project management experience.
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Requirements:
BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field preferred; may substitute relevant experience for education.
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Salary:
$120,000 - $150,000 per year