Quality Assurance Specialist

Job Summary

Responsibilities

• Provide Quality oversight for daily operations
• Conduct internal ISO 9001 audits
• Drive continuous improvement through PPI initiatives
• Support post-market and development activities for consumables, hardware, and Next Generation Sequencing (NGS) software
• Lead product transfers
• Manage non-conformances
• Investigate customer complaints
• Execute effective CAPAs
• Partner in Root Cause Analysis investigations
• Evaluate deviations
• Lead rapid-response containment strategies
• Review and approve site procedures
• Manage engineering change controls
• Approve training documentation of moderate to high complexity
• Integrate AI tools into Quality workflows
• Modernize compliance tracking
• Report key metrics

Qualifications

• Bachelor's Degree (Life Sciences or related field preferred)
• 2+ years of Quality Assurance experience in the biotechnology industry
• Strong working knowledge of ISO requirements and hands-on internal auditing experience
• Proven problem-solving and Root Cause Analysis expertise
• Exceptional written and verbal communication skills

Skills

• QC Review
• Quality Assurance (QA)

Benefits

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including:

• medical
• prescription
• dental
• vision
• AD&D
• life insurance
• short-term disability
• a 401K plan (all benefits are based on eligibility)