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Compliance Auditor II
2 weeks ago
FUJIFILM Diosynth Biotechnologies seeks a highly skilled Regulatory Compliance Specialist II - Audit and Inspection Expert to join our team.
In this critical role, you'll collaborate with site management to develop and implement effective quality systems, ensuring the organization's products meet the highest standards of quality, safety, and efficacy.
Main Responsibilities- Work collaboratively with site management to instill a 'Quality Culture' by coaching in the application of GMP Principles.
- Mentor peers towards achieving organizational and individual goals.
- Provide QA support to the organization during client audits and regulatory inspections to determine suitability, effectiveness, and compliance with applicable standards and regulations.
- Support client due diligence and Quality audits as well as regulatory inspections.
- High school diploma or GED and six (6) years of experience in a regulated industry, including two (2) years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
- Associate degree in a related science concentration with 4 years of experience in a regulated industry, including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
- Bachelor's degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
- Master's degree in a related science concentration with 1 year of experience of cGMP supporting pharmaceutical or biotechnology products.
