Senior Compliance Specialist
Technology
Job Description
Schedule: 2nd Shift - Tuesday - Saturday from 2:00 PM - 10:30 PM ET
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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.
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Responsibilities:
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- Ensure all activities within scope are conducted in compliance with applicable regulatory requirements, including Good Manufacturing Practices (GMP)
- Perform finished product and AQL inspections according to established standards, specifications, and timelines
- Trend AQL failures and support root cause analysis investigations for quality incidents, implementing preventive measures as needed
- Ensure all batch release activities comply with GMP requirements
- Manage the sampling, storing, monitoring, and maintenance of finished product retention samples according to established procedures and timelines
- Perform and manage annual inspections of retention samples
- Support the creation of new material and product specifications
- Perform document creation and revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines
- Support the department Quality Management System, including Change Control, Deviations, and CAPA processes
- Support the department documentation archival system
- Collaborate closely with production on the shopfloor to ensure quality standards are maintained throughout the product lifecycle
- Manage, escalate, and resolve quality-related issues in a timely and effective manner
- Support monitoring and analysis of quality performance metrics, implementing corrective actions as needed
- Conduct internal audits of manufacturing processes to verify ongoing compliance with in-house specifications and government regulations
- Establish auditing requirements, quality standards, and test methods in accordance with applicable regulations
- Review, document, and complete inspections of returned goods
- Support quality walkthroughs and participate in internal and external audits and regulatory inspections as a subject matter expert
- Support risk management strategies to identify and mitigate potential quality issues
- Foster a culture of quality and continuous improvement across the organization
- Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures
- 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
- Proficiency in interpreting complex regulatory, technical, and explicit documentation to ensure adherence to quality and compliance requirements
- Solid understanding of government regulations related to manufacturing compliance
- Ability to establish and implement quality standards, auditing frameworks, and test methodologies
- Excellent analytical and problem-solving skills with sound judgment in ambiguous situations
- 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
- High attention to detail with a commitment to accuracy and thoroughness
- Ability to work independently, manage multiple priorities, and operate effectively on a 2nd shift schedule
- Demonstrated ability to contribute to and support cross-functional organizational goals
- 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
- Proven experience conducting internal audits of manufacturing processes
- Experience establishing auditing frameworks, quality standards, and test methods
- Track record of working with GMP requirements, government regulations, and in-house compliance specifications
- Experience managing batch release activities, retention samples, and finished product inspections
- Experience supporting Quality Management Systems, including Change Control, Deviations, and CAPA
- Experience participating in internal and external audits and regulatory inspections, including serving as a subject matter expert
- Experience representing an organization in project-based or cross-functional capacities
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