Senior Quality Assurance Specialist

Senior Quality Assurance Specialist responsible for implementing systematic quality activities, conducting audits, and ensuring regulatory compliance at a life sciences company. The role involves document control, CAPA management, validation activities, and preparation for regulatory inspections.

Responsibilities

• Manage document control activities using electronic database systems
• Conduct and report on periodic internal audits per established schedule
• Review batch records and assist with material release or hold decisions
• Write, review, and revise nonconformances, CAPAs, and quality procedures
• Prepare validation plans and reports; execute validation activities

Requirements

• Bachelor's degree in science, engineering, or related field
• Minimum 8 years of quality assurance function experience
• Lead auditor certification or ASQ CQE/CQA certifications preferred
• Proficiency with document control processes and electronic databases
• Strong understanding of ISO 13485, FDA Quality System Requirements, and ISO 14971
• Advanced Microsoft Office skills including Excel for data analysis
• Demonstrated ability to lead investigations and determine material dispositions

Compensation: $89,300.00 - $146,900.00