Quality Systems and Compliance Specialist

Pay: $50,000 per year

Schedule: 1st shift
Type of job: Temporary to hire

Responsibilities

• Support Quality Systems, including Change Control and Corrective and Preventive Actions (CAPAs).
• Manage and maintain Standard Operating Procedures (SOPs), document control, and quality records.
• Support audit and FDA inspection readiness activities, ensuring compliance with applicable regulations and procedures.
• Administer and maintain the Learning Management System (LMS), including training records and compliance tracking.
• Support Supplier Quality activities and Annual Product Reviews (APRs).
• Track and maintain customer complaints and Supplier Corrective Action Requests (SCARs).
• Support validation documentation and ensure adherence to Data Integrity (ALCOA+) principles.
• Monitor quality metrics and compliance while identifying opportunities for continuous improvement.
• Collaborate cross-functionally to ensure quality and regulatory requirements are consistently met.

Requirements

• High school diploma or equivalent
• 2+ years of experience with pharmaceutical quality systems