What are the responsibilities and job description for the Quality Systems and Compliance Specialist position at Astrix?
Pay Rate Low: 50000 | Pay Rate High: 50000
Pay Rate Low: 50,000 | Pay Rate High: 50,000
Our client is a long-standing leader in contract manufacturing. They are hiring a Quality Systems and Compliance Specialist to join their team!
Schedule: 1st shift
Type of Job: Temp to hire
Responsibilities
INDBH
Pay Rate Low: 50,000 | Pay Rate High: 50,000
Our client is a long-standing leader in contract manufacturing. They are hiring a Quality Systems and Compliance Specialist to join their team!
Schedule: 1st shift
Type of Job: Temp 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.
- High school diploma or equivalent
- 2 years of experience with pharmaceutical quality systems
INDBH