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Eurofins Clinical Diagnostics · 12 hours ago

Quality Assurance Manager

Centennial, CO

Full-time

Onsite

Senior Level, Lead/Staff

$100K/yr - $120K/yr

15+ years exp

Eurofins Scientific is an international life sciences company that provides analytical testing services across multiple industries. The Manager of Quality Assurance will lead quality assurance efforts within the DPT network of laboratories, ensuring compliance with regulations and maintaining inspection readiness.

Biotechnology

Responsibilities

Manages assigned personnel activities within the RA/QA department (e.g., timecards, time off); collaborate with Director RA/QA in employee performance evaluations

Coaches, reviews, manages, and terminates assigned staff. Sets goals for assigned employees

Counsels assigned Quality Systems Specialists regarding problems / issues encountered in daily activities

Identifies continuous improvement opportunities and coordinate actions to improve processes; proactively manage critical issues of a quality nature. Identifies, coordinates and/or implements tools and process improvements to promote efficiency and process improvements through the organization

Creates and maintains relationships with other managers within the Eurofins DPT network that is productive and promotes teamwork and change

Consults on quality-related questions and issues from internal and external clients

Supports the company and department in meeting its goals and initiatives

Serves as a liaison for the organization to outside vendors, clients and auditors

Performs duties in compliance with all applicable regulatory and accrediting agencies

Supports the Director of RA/QA in Executing organizational and department initiatives

Preparing materials as requested by Executive Management (trending data, Management Review, customer-specific meetings)

Provides perspective and Subject Matter Expertise on the interpretation of Clinical Laboratory Regulatory requirements that impact the Company’s operations and regulatory compliance

Provides Quality Management support for QMS-related activities across our network of laboratories

Assists in designing and developing overall corporate quality system

Reviews and approves quality event investigations (including corrective action plans) to ensure thorough and high-quality records

Ensures laboratory practices are aligned and consistent across the organization, taking best practices into account helping to maintain audit-readiness throughout the organization, preparing laboratories for key inspections as well as internal and external audits

Oversees that new actions implemented as a result of customer complaints or deviations are to be rolled out to all laboratories

Trends Quality Management System timeline through the lifecycle of items (deviations, complaints, corrected reports, SCARs, CAPAs, etc.) for Operations Senior Management

Oversees training policies and procedures to ensure compliance with regulations and standards

Performs duties and tasks in a timely and compliant manner, ensuring accurate documentation and conclusions

Represents Eurofins DPT for client and regulatory-based audits/inspections

Qualification

Quality Assurance ManagementLaboratory Operations ExperienceAuditing ExperienceCLIA/CAP/FDA RegulationsRoot Cause AnalysisQuality Management SystemTeam LeadershipCommunication SkillsProblem Solving