Quality Assurance Compliance Specialist

Quality Assurance Specialist I - Supplier Quality emphasis

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Join our client's dynamic pharmaceutical team as a Quality Compliance Specialist in sunny Orlando, FL, dedicated to excellence in healthcare solutions!

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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.

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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.

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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.

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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.