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Quality Assurance Compliance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Compliance Associate to join our team at Alene Candles LLC & Midwest. As a key member of our quality team, you will be responsible for ensuring compliance with regulatory requirements, company quality standards, and industry best practices.
Key Responsibilities- Develop, implement, and maintain quality compliance policies and procedures for all manufacturing sites.
- Ensure compliance with relevant regulatory requirements, including FDA regulations, ISO standards, and other applicable quality standards.
- Develop and deliver training programs on quality compliance policies, procedures, and regulations for employees at all levels.
- Ensure that staff members are adequately trained to perform their roles in compliance with quality standards and regulatory requirements.
- Establish and maintain comprehensive documentation systems to track compliance activities, audit findings, and corrective actions.
- Ensure accurate and timely completion of quality-related documentation, including batch records, standard operating procedures (SOPs), and quality reports.
- Collaborate with the Quality Assurance team to implement and maintain quality management systems, including document control, change control, and deviation management.
- Provide support for investigations into quality issues, including root cause analysis and corrective action implementation.
- Identify opportunities for process improvement and efficiency gains within the quality compliance function.
- Lead or participate in continuous improvement projects aimed at enhancing quality systems and processes.
- Utilize data analysis and performance metrics to drive improvement initiatives and monitor progress.
- Collaborate with cross-functional teams, including Operations, Regulatory Affairs, Quality Control, and Supply Chain, to ensure alignment on quality compliance objectives and initiatives.
- Serve as a liaison between manufacturing sites and corporate quality functions to facilitate communication and knowledge sharing.
- Bachelor's degree in a relevant field (e.g., Quality Assurance, Regulatory Affairs, Engineering, Chemistry, or related discipline).
- 1-3 years of experience in quality compliance or regulatory affairs roles.
- In-depth knowledge of regulatory requirements, quality management systems, and industry best practices (e.g., FDA regulations, ISO standards).
- Ability to travel 15%-20% of the time as needed.
