POSITION SUMMARY:

The Supplier Quality Assurance Specialist II will provide support for Supplier Quality Management activities

RESPONSIBILITIES:

• Assist with supplier approval process.
• Perform supplier audits and manage supplier audit schedule under the guidance of a senior level Quality Assurance employee.
• Manage supplier related Nonconformance reports, Corrective and Preventive Actions reports.
• Manage the document archiving and retrieving process.
• Assist or lead problem-solving activities.
• Identifies and implements process improvements
• Maintain compliance with all company policies, quality systems, procedures and ISO and GMP requirements.
• Ability to work with cross-functional teams in problem solving.
• Assist in collecting and evaluating data to support quality metrics.
• Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
• Safeguarding the privacy and security of protected health information and European Union personal data.
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
• Perform other duties as assigned by supervisor.

QUALIFICATIONS:

• Two (2) years experience in a regulated industry.
• Previous experience in Supplier Quality Assurance preferred.
• Attention to detail with an ability to follow directions for creating quality system records.
• Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
• Ability to work with minimal direction, and utilize good problem-solving skills.
• Excellent planning and organization skills.
• Effective analytical skills.

EDUCATION:

Bachelor’s Degree (science discipline preferred)