Quality Records Specialist

Title: Sr QA Technician - Records Specialist

Location: Greenville, NC 27834

Duration: 12 Months

Pay: $25.45/hr.

Position Summary:

• The Sr. Quality Technician, Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals.
• Ensures the site operates in compliance with regulatory standards that ensures product quality, avoids stoppages and reinforces customer satisfaction.

Key Responsibilities:

• Follow all job-related safety, quality, compliance, and training requirements.
• Review electronic manufacturing and quality data, including audit trails and associated records, to ensure completeness, accuracy, compliance with procedures, and adherence to data integrity requirements.
• Identify and assess discrepancies, atypical events, data integrity concerns, and potential compliance issues identified during review.
• Communicate and coordinate with Manufacturing, Quality, Engineering, and other departments to resolve issues identified during review.
• Apply risk-based decision-making to ensure appropriate controls are in place for product quality, patient safety, sterility assurance, and data integrity.
• Escalate deviations, discrepancies, and compliance concerns to the appropriate functional area and Quality management.
• Perform review activities of moderate complexity with limited supervision while ensuring compliance with GMP requirements and current procedures.

Education:

• High school diploma or equivalent required.
• Associates degree or higher in Science or Technology is preferred.