What are the responsibilities and job description for the Quality Assurance Compliance Specialist position at Collabera?
Job Summary:
The Quality Assurance Compliance Specialist supports the execution of quality and regulatory functions to ensure organizational compliance with applicable regulations, standards, and corporate policies. This role focuses on quality system administration, audit support, corrective action tracking, and cross-functional quality integration.
Key Responsibilities:
• Support external audit activities, including FDA, FDB, ISO, and registrar audits.
• Audit organizational quality systems and processes to ensure compliance.
• Administer quality system processes such as CAPAs and internal audits.
• Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports.
• Track and trend compliance activities and generate metrics for management reviews.
• Assist in providing timely feedback on open corrective actions.
• Participate in cross-divisional initiatives to integrate quality system information.
• Review and update quality system procedures as necessary.
• Assist in developing and conducting quality system training programs.
• File and maintain quality records, including audit reports, IACAs, and CAPAs.
• Ensure all responsibilities are carried out in compliance with governing regulations and standards.
• Perform other duties as assigned.
Required Qualifications:
• Bachelor’s degree or equivalent combination of education and experience.
• 4 years of experience in quality assurance, compliance, or related functions.
• Experience supporting external audits and internal quality processes.
• Proficiency in quality system administration, CAPA management, and audit reporting.
• Strong organizational, communication, and documentation skills.
Preferred Qualifications:
• Experience in pharmaceutical, medical device, or regulated industry environments.
• Familiarity with regulatory standards such as ISO, FDA, or equivalent.
• Experience conducting quality system training sessions.
Benefits (Contractual Roles):
The company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $30/hr to $35/hr
Salary : $30 - $35