Quality Specialist I

Requirements

• Reviews and approves quality control and verifications for the routine testing of biological samples.
• Maintains accurate records and documentation as required by established procedures and good documentation practice regulations.
• Supports the archival record organization and classification maintenance process.
• Partners with personnel from various departments to resolve routine problems.
• Analyzes environmental monitoring and assists with problem investigations.
• Maintains test batches and results in the laboratory information system.
• Completes constructive investigations and resolves batch review discrepancies.
• Serves as a resource for moderate complexity corrections and/or clarifications.
• Provides mentorship, guidance, and training to newer staff.
• Assists with internal and external audits.
• Analyzes testing and QC data to identify and/or investigate trends.
• Resolves a wide range of complex quality and production problems to ensure test results meet all quality attributes prior to release.
• Maintains working knowledge of assay processes performed at the laboratory.

Benefits

• Medical, dental, and vision insurance
• 401(k) plan
• Paid time off
• Life insurance
• Accident insurance
• Flexible spending accounts
• Employee assistance program