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Assay Supervisor, Validation and Verification

Company: Quidel
Location: San Diego
Posted on: November 23, 2021

Job Description:

Quidel Corporation is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia , Solana , Lyra , Triage and QuickVue , Quidel's comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel's mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.

The V&V Supervisor is responsible for overseeing laboratory technicians and day to day activities in support of activities relating to method feasibility, validation, verification, and transfer including oversight of change controls, protocol generation, sample preparation and data evaluations. Responsibilities also include providing Assay Verification and Validation (V&V) support for new products, assay integration, technology transfer and other assay V&V activities associated with new product development, manufacturing, and marketing.

ESSENTIAL FUNCTIONS

  • Oversee laboratory and technicians and mentor technicians for development
  • Actively participates on design teams, understands project goals and timelines, and provides leadership to ensure product launch success
  • Actively communicates project status, challenges, concerns, and resource constraints to area management
  • Writes design control documentation and executes/oversees associated test and risk management activities
  • Works with R&D to develop, optimize and integrate assay V&V
  • Maintains project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process
  • Provides guidance to V&V, R&D or other functions as needed
  • Carries out duties in compliance with established business practices and policies
  • Provides support and guidance for troubleshooting method issues
  • Resolves complex technical problems through teamwork, communication, and application of technical expertise
  • Supports improvement verifications, validations, and transfers
  • Develops, reviews, or approves execution protocols and group generated data
  • Oversee studies, reviews protocol execution, and approves summary reports
  • Effectively communicates with support groups across the company
  • Maintains high levels of communication with other laboratory teams to support the coordination of shared resources
  • Performs evaluations and action-item assignments related to change controls
  • Reviews and approves document changes for SOPs and other technical documents
  • Ensures group members have and use appropriate engineering controls, safety procedures and PPE. Encourages a strong culture of team and individual safety awareness and accountability
  • Coordinates cross-functionally across the site to support project planning and execution
  • Ensures an appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed
  • Performs analysis and determines appropriate actions in investigations, deviations, CAPAs, and continuous improvement to ensure compliance with all GMP requirements
  • Anticipates and troubleshoots issues regarding processes, procedures, and documentation
  • Utilizes scientifically sound, risk-based approaches to determine the impact and root cause of issues as they are identified
  • Develops and implements corrective actions
  • Leads and develops best practices
  • Independently supports the assay V&V vision on the project teams
  • Performs other tasks as assigned.

    EDUCATION/EXPERIENCE
    • BS/BA degree in a science/business/technical discipline with a minimum of 5+ years of experience in computer system validation.
    • In depth knowledge of FDA guidelines relevant to 21 CFR Part 11 compliance requirements including 510(k) and PMA submissions.
    • Ability to translate compliance priorities effectively and efficiently into design, testing, documentation, and project objectives.
    • Experience in development and implementation of standards, procedures, and guidelines in support of validated operational processes.
    • Knowledge of FDA design control requirements.
    • Ability to clearly articulate design verification and validation process concepts to the business community through written and oral presentations.

      KNOWLEDGE/SKILLS
      • Strong analytical and problem-solving skills
      • Good organizational skills, and the ability to manage multiple tasks
      • Experience in product development and experimental design
      • Ability to work within cross functional teams
      • Strong communication skills, written and verbal
      • Must exhibit professionalism, confidence, maturity, a desire to succeed, proactivity, and self-motivation
      • Strong knowledge of relevant analytical tools
      • Ability to participate in planning and managing projects
      • Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management)
      • Knowledge of related quality systems regulations and processes
      • Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
      • Ability to successfully complete projects while maintaining sensitivity to political issues
      • Persuasive, encouraging, and motivating
      • Excellent negotiation and conflict resolution skills
      • Flexible during times of change
      • Ability to work in a startup-like culture and conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
      • Ability to understand and flex to different communication styles of team members and contractors who come from a broad spectrum of disciplines
      • Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments
      • Ability to apply V&V expertise in the development and implementation of functional strategies to support corporate goals and objectives.

        Before you apply, please make sure you share Quidel' s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven , focused on execution , and new product oriented . We succeed by being determined , optimistic team players .

        Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: Quidel, San Diego , Assay Supervisor, Validation and Verification, Other , San Diego, California

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