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Quality Assurance Analyst
2 months ago
About ITS Logistics
Are you prepared to unlock your potential and contribute to one of the most rapidly expanding and dynamic logistics firms in the United States? ITS Logistics stands as a leading Third-Party Logistics provider, delivering innovative supply chain solutions. Our commitment to exceptional service, unparalleled industry expertise, and a strong focus on innovation and technology drives our mission to enhance the quality of life through excellence in all our endeavors.
At ITS, we prioritize your personal and professional development, equipping you with the tools, resources, and support necessary to realize your full potential, collaborate with like-minded colleagues, and embrace boundless opportunities. By becoming part of our exceptional team, you will join an organization that appreciates your unique talents, fosters your pursuit of excellence, and acknowledges your steadfast dedication to achieving our collective objectives.
We empower our team members to excel in their respective domains by cultivating a culture of collaboration, healthy competition, and unwavering resilience. We believe that together, we can overcome any challenge and achieve extraordinary success.
About the Role
The Quality Assurance (QA) Specialist plays a crucial role in overseeing quality across business sectors that necessitate compliance with current good manufacturing practices.
- Design, implement, and sustain quality management systems in alignment with 21 CFR 820 and ISO 13485 standards.
- Provide QA oversight for equipment, utilities, and facilities.
- Conduct internal audits to evaluate adherence to quality management systems and regulatory standards.
- Collaborate with internal and external auditors, as well as regulatory bodies during audits and inspections.
- Investigate nonconformities and implement corrective and preventive measures to address root causes and prevent recurrence.
- Review and authorize documentation, including control records, validation protocols, and change management.
- Facilitate the completion of Risk Analysis documentation for both new and existing processes.
- Deliver cGMP and controlled document training for new hires and provide annual refresher training for all warehouse departments.
- Maintain the professional competence, knowledge, and skills necessary for effective performance of all assigned responsibilities.
- Perform other assigned duties as required within the Quality department.
- Work independently in an on-site capacity.
About the Qualifications
- Bachelor's degree in engineering, life sciences, or a related field is preferred but not mandatory.
- Possess knowledge and practical experience with ISO quality system standards: ISO 13485 and FDA 21 CFR 820.
- Ability to collaborate effectively with various teams to ensure compliance with quality and regulatory requirements, internal processes, and policies.
- Capability to prioritize tasks in a deadline-driven environment.
- Experience in leading risk management initiatives, including risk assessment and mitigation strategies.
- Strong written and verbal communication and organizational skills.
- Proficient in PC applications – Word, Excel, PowerPoint, and Outlook.
Compensation
Salary Range: $65,000 (DOE) with a performance-based bonus structure. A comprehensive multi-tiered benefits plan, paid time off, and a matching 401k are included.
