Senior Compliance Specialist

Job Description

Schedule: 2nd Shift - Tuesday - Saturday from 2:00 PM - 10:30 PM ET

In this role, you will serve as a key contributor to maintaining the integrity of our manufacturing operations by ensuring all procedures align with in-house specifications and applicable government regulations. Operating with a high degree of independence, you will apply sound judgment to drive compliance initiatives, support organizational goals, and represent the company on specific projects. This is a critical role that directly impacts product quality, regulatory standing, and operational efficiency.

Responsibilities:

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• Ensure all activities within scope are conducted in compliance with applicable regulatory requirements, including Good Manufacturing Practices (GMP)
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• Perform finished product and AQL inspections according to established standards, specifications, and timelines
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• Trend AQL failures and support root cause analysis investigations for quality incidents, implementing preventive measures as needed
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• Ensure all batch release activities comply with GMP requirements
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• Manage the sampling, storing, monitoring, and maintenance of finished product retention samples according to established procedures and timelines
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• Perform and manage annual inspections of retention samples
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• Support the creation of new material and product specifications
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• Perform document creation and revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines
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• Support the department Quality Management System, including Change Control, Deviations, and CAPA processes
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• Support the department documentation archival system
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• Collaborate closely with production on the shopfloor to ensure quality standards are maintained throughout the product lifecycle
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• Manage, escalate, and resolve quality-related issues in a timely and effective manner
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• Support monitoring and analysis of quality performance metrics, implementing corrective actions as needed
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• Conduct internal audits of manufacturing processes to verify ongoing compliance with in-house specifications and government regulations
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• Establish auditing requirements, quality standards, and test methods in accordance with applicable regulations
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• Review, document, and complete inspections of returned goods
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• Support quality walkthroughs and participate in internal and external audits and regulatory inspections as a subject matter expert
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• Support risk management strategies to identify and mitigate potential quality issues
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• Foster a culture of quality and continuous improvement across the organization
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• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures
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• Contribute to the completion of organizational projects and goals, representing the organization on specific projects
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Skills:

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• Strong knowledge of manufacturing quality assurance principles, practices, and GMP regulations
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• Proficiency in interpreting complex regulatory, technical, and explicit documentation to ensure adherence to quality and compliance requirements
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• Solid understanding of government regulations related to manufacturing compliance
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• Ability to establish and implement quality standards, auditing frameworks, and test methodologies
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• Excellent analytical and problem-solving skills with sound judgment in ambiguous situations
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• Strong written and verbal communication skills for internal and external stakeholder engagement, including the ability to advise on risk management strategies and present findings effectively
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• High attention to detail with a commitment to accuracy and thoroughness
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• Ability to work independently, manage multiple priorities, and operate effectively on a 2nd shift schedule
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• Demonstrated ability to contribute to and support cross-functional organizational goals
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• Proven ability to identify discrepancies, recommend corrective and preventive actions, and escalate GMP non-compliance issues appropriately
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Experience:

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• 6 to 9 years of experience in quality assurance, quality control, or a related manufacturing compliance role
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• Proven experience conducting internal audits of manufacturing processes
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• Experience establishing auditing frameworks, quality standards, and test methods
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• Track record of working with GMP requirements, government regulations, and in-house compliance specifications
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• Experience managing batch release activities, retention samples, and finished product inspections
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• Experience supporting Quality Management Systems, including Change Control, Deviations, and CAPA
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• Experience participating in internal and external audits and regulatory inspections, including serving as a subject matter expert
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• Experience representing an organization in project-based or cross-functional capacities
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