Regulatory Compliance Officer II
3 weeks ago
Job Summary: As a seasoned Quality Assurance Specialist, you will play a pivotal role in developing and implementing high-quality processes that adhere to strict regulatory standards. With your exceptional skills in Quality Risk Management, you will drive business success and foster long-term partnerships.
Key Responsibilities:
- Promote a culture of compliance throughout the organization, emphasizing the importance of quality and safety.
- Support continuous improvement initiatives by identifying areas of opportunity and collaborating with cross-functional teams to optimize processes.
- Conduct thorough risk assessments to minimize potential hazards.
- Analyze complex data sets to inform strategic decisions.
- Collaborate with senior leadership to develop effective quality policies and procedures.
Requirements:
- Bachelor's degree in a scientific discipline with 6+ years Quality/cGMP experience in the pharmaceutical industry.
- Proven track record in process validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management.
- Knowledge of 21CFR Part 11, Electronic Records and Signatures, and data integrity principles.
Estimated Salary: $120,000 - $180,000 per year.
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