QUALITY SYSTEMS SPECIALIST at FRAGRANCE MANUFACTURING INC

Description

The Quality Systems Specialist ensures that FMI’s products and processes comply with regulatory and quality requirements. This role supports our Quality Management System (QMS), adheres to Good Documentation Practices (GDP), manages calibration programs, and provides timely and accurate support to internal teams and external customers.

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.