Quality Assurance Specialist

4 weeks ago

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

Geneoscopy, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products and services meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Assist in maintaining compliance with all applicable regulations and requirements, including CLIA, CAP, NYS DOH, FDA, and ISO.
  • Maintain 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.
  • Maintain paper and electronic files so that they are well organized and can be easily retrieved.
  • Manage periodic document reviews to ensure adherence to internal procedures.
  • 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 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.

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.

Benefits:

  • Base salary range: annually determined based on the candidate's experience, knowledge, and abilities.
  • Bonus: discretionary annual bonus based on a percentage of the employee's base salary.
  • Benefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.

Additional Information:

Geneoscopy, Inc. is committed to embodying the following 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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