QUALITY SYSTEMS SPECIALIST

Key Responsibilities

• Support and maintain FMI’s Quality Management System (QMS).
• Conduct Product Worksheet (PWS) reviews within 72 hours of receipt.
• Oversee Good Documentation Practices (GDP) training processes.
• Track and update Non-Conformance      Reports (NCR) and Corrective and Preventive Actions (CAPA) within 48      hours.
• Create logbooks within 1 day and perform reviews/archival within 2 weeks.
• Manage calibration for QC      instrumentation, ensuring no late or missed calibrations.
• Maintain signature logbooks within 1 week of the new employee's start date.
• Provide timely responses to internal and external customer requests (within 24 hours).
• Deliver weekly updates on customer requests until they are resolved.
• Participate in audits and regulatory inspections as needed.
• Complete all company-required training on time and maintain 8 hours of regulatory-related training annually.

Qualifications

Required:

• Bachelor’s degree in a science-related field or equivalent education/experience.
• Minimum 1 year of experience in a regulatory or quality role.
• Strong knowledge of Quality      Management Systems, cGMP, and GDP requirements.
• Familiarity with FDA audit processes.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Strong attention to detail and excellent organizational skills.
• Ability to effectively communicate in English, verbally and in writing.

Preferred:

• Certification(s) in regulatory/quality disciplines.
• Experience with ERP systems (e.g., SyteLine).
• Previous involvement in professional or community organizations.

Core Competencies

• Strong time management and ability to manage multiple priorities.
• Customer-focused, with excellent problem-solving skills.
• Integrity and accountability in all actions.
• Adaptability and resilience under pressure.
• Team-oriented with strong collaboration skills.