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Regulatory and Quality Assurance Specialist II (Hybrid)
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Job Description
- Req#: REGUL008416
Employer Industry: Biotechnology and Healthcare
Why consider this job opportunity:
- Salary up to $120,000 annually
- Opportunity for career advancement and growth within the organization
- Comprehensive benefits package offered
- Supportive and collaborative work environment
- Chance to make a significant impact on regulatory compliance and quality assurance
What to Expect (Job Responsibilities):
- Implement, monitor, maintain, and improve the company's Quality System
- Facilitate quarterly meetings with medical directors to provide regulatory and quality updates
- Ensure compliance with federal, state, and international regulatory agencies
- Maintain and improve deviation/non-conformance systems and report events to regulatory bodies
- Conduct audits for departments and systems to assure compliance with regulations and standards
What is Required (Qualifications):
- Bachelor's degree or equivalent combination of training and experience
- High level of interpersonal skills to handle sensitive and confidential situations
- Proficiency in various computer software applications, including MS Word, Excel, and PowerPoint
- Strong aptitude for analyzing data and auditing processes
- Excellent verbal and written communication skills
How to Stand Out (Preferred Qualifications):
- Prior laboratory experience
- Knowledge of industry, federal, and state regulations, and licensing processes
- Ability to organize and lead collaborative teams for quality projects
- Experience in a fast-paced, dynamic environment
- Occasional travel willingness (up to 25%)
#Biotechnology #QualityAssurance #RegulatoryCompliance #CareerOpportunity #HealthcareJobs
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