Quality Specialist I

Job Summary:

The Quality Specialist I is a mid-level role responsible for overseeing and enhancing quality systems, managing complex nonconforming product issues, and ensuring comprehensive compliance with regulatory standards. This role demands a proactive approach to maintaining and improving quality system performance, mentoring teams, and serving as a leading Subject Matter Expert (SME) in quality systems applicable to storage and distribution processes.

Job Responsibilities: _(Primary Duties, Roles, and/or Authorities)_

• Lead the evaluation and disposition of held or nonconforming products with a focus on minimizing Zero Escape incidents.
• Oversee intracompany claims and drive the resolution process.
• Conduct and manage QMS Audits, ensuring rigorous compliance and continuous improvement.
• Analyze metric data to identify trends and implement strategic quality improvements.
• Provide advanced operations support and maintain the DR License with utmost diligence.
• Act as the primary SME for ISO 13485, 21 CFR 820, and Corporate Policies/Procedures, ensuring strict adherence and application.
• Ensure the site’s compliance with local wholesale drug licenses as the designated representative.
• Mentor and train team members on QMS requirements and facilitate continuous process improvement initiatives.
• Maintain a high level of proficiency with SAP, WMS, and other ERP platforms, providing expert guidance and support.
• Assume responsibility for other positions during times of urgency, breaks, absences, or vacation to maintain operational continuity.
• Expected travel can be up to 25% of the time.

Education and Experience:

• Bachelor’s degree preferred.
• Associate degree, or a combination of equivalent education and experience, required in lieu of a bachelor's degree.
• Minimum of 2 years of experience in a regulated environment, with a demonstrated track record of quality system management.
• Industry-recognized certification in a Quality System Element or specialty (e.g., ASQ Certified Quality Auditor) is highly desirable.
• Advanced proficiency with SAP, WMS, and other ERP platforms is required.
• Experience with Boards of Pharmacy and regulatory audits required.
• Experience as a designated representative preferred.

Knowledge and Skills:

• Demonstrated leadership ability and experience in guiding teams to achieve quality objectives.
• Strong analytical thinking and problem-solving skills with a proactive approach to addressing underperformance.
• Exceptional technical writing skills and the ability to communicate complex quality concepts clearly.
• Expertise in Microsoft Office Suite and advanced knowledge of ERP systems.

Physical Demands:

The physical demands described are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, in accordance with the Americans with Disabilities Act of 1990 and applicable state and local laws. While performing this job, the associate is regularly exposed to episodes of walking, standing, stooping, kneeling, hearing, long episodes of sitting, frequent use of hands and fingers, or typing which can include repetitive motion of the wrists, hands or fingers.

Work Environment:

This position typically works in a normal office environment. The noise level in the work area is quiet to moderate. At times, position may be required to support operational activities in the distribution center.