Quality Assurance Compliance Specialist
4 weeks ago
Quality Assurance Specialist I - Supplier Quality emphasis
Join our client's dynamic pharmaceutical team as a Quality Compliance Specialist in sunny Orlando, FL, dedicated to excellence in healthcare solutions
Quality Specialist Benefits:
- M-F 9-6 hours, no off shifts or weekends
- Comprehensive health and 401(k) programs.
- Professional development opportunities within pharmaceutical manufacturing
- Vibrant company culture in a convenient Orlando location.
Quality Compliance Specialist Responsibilities:
- Conduct investigations for sterile and non-sterile pharmaceutical compounding, shipping, receiving, and product-related events.
- Collaborate with department managers for root cause analysis and solution implementation.
- Write and review deviations, out-of-specification investigations, and corrective and preventive actions (CAPAs).
- Monitor investigation progress and communicate delays to management.
- Perform effectiveness checks to ensure CAPAs are implemented successfully.
- Communicate investigation findings for data tracking and trend analysis.
- Conduct routine audits of processes and procedures for compliance.
- Collaborate with pharmacists and department managers to schedule and complete investigations.
- Conduct internal audits in compliance with SOPs and regulatory requirements.
- Develop auditing tools, define auditing scope, and schedule auditing activities.
- Educate and train audit recipients to address identified gaps.
- Undertake special projects and delegated duties as assigned.
Quality Compliance Specialist Requirements:
- High school diploma required; post-high school education preferred.
- 2+ years of pharmacy or pharmaceutical compounding or manufacturing experience.
- Excellent communication and interpersonal skills.
- Experience in implementing preventative measures and performing effectiveness checks.
Quality Compliance Specialist Preferred Qualifications:
- College degree in a science-related field.
- Familiarity with quality principles and tools such as DMAIC and Root Cause Analysis.
- 2+ years of prior auditing experience in a regulated facility.
- Auditing certification by a recognized organization such as ASQ.
- Ability to host professional meetings and presentations.
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