Quality Assurance Specialist I

4 weeks ago

Saint Louis, United States Geneoscopy, Inc. Full time
Job Summary

Geneoscopy, Inc. is seeking a highly skilled Quality Assurance Specialist I to join our team. The successful candidate will be responsible for ensuring that our products and services meet the requirements under the Quality Management System while maintaining and managing the Company's document control system to maintain compliance with both Clinical Laboratory Improvement Amendments (CLIA) and Quality System Regulation (21 CFR 820).

Key Responsibilities
  • Maintain compliance with all applicable regulations and requirements (CLIA, CAP, NYS DOH, FDA, ISO, etc.).
  • Manage the process for document control including document creation, revision, and obsolescence.
  • Ensure documents are approved by the appropriate personnel according to applicable policies and procedures.
  • Ensure documents are formatted in a consistent way and all aspects of the document control process are completed.
  • Manage paper and electronic files so that they are well organized and can be easily retrieved.
  • Conduct training sessions for staff on the use and understanding of the document control system.
  • Assist users in navigating and effectively utilizing the electronic Quality Management System (eQMS).
  • Manage the document control module in the eQMS including evaluations of updates and software validation as needed.
  • Support equipment management including but not limited to instrument calibration and generation of monthly reports as needed.
  • Participate in internal and external audits.
  • Review records for accuracy.
  • Coordinate quality processes.
  • Participate in Management Review meetings.
  • Perform work under general supervision, navigating moderately complex issues and problems.
  • Exemplify solid working knowledge of the subject matter.
  • Other duties as assigned.
Requirements
  • Bachelor's Degree required.
  • Possess at least 2 years of experience in a CLIA/CAP or QSR-regulated environment.
  • Possess strong attention to detail to ensure the accuracy and integrity of all documents managed.
  • Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.
  • Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.
  • Possess high ethics and conduct business in the most professional manner.
  • Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.
  • Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.
Additional Information

Geneoscopy's Core Values

  • Integrity - we do the right thing through our words, actions, and behaviors
  • Courage - step up, speak up, stand out
  • Agility - think and act fast, embracing change
  • Passion - for our customers, our people, our work, and for excellence
  • Collaboration - our differences are assets


Physical Demands

  • Employees may be required to lift routine office supplies and use standard office equipment.
  • Must possess the ability to sit and/or stand for long periods.
  • Must possess the ability to perform repetitive motion.

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