Quality Assurance Specialist I

This position must be onsite at the Geneoscopy office in St. Louis, Missouri.

This position assists in ensuring that Geneoscopy's 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).

RESPONSIBILITIES

• Assist in maintaining compliance with all applicable regulations and requirements (CLIA, CAP, NYS DOH, FDA, ISO, etc.).
• 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 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.

EDUCATION REQUIREMENTS

• Bachelor's Degree required.

QUALIFICATIONS

• 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.
• Preferred Additional Experience:
  • Hands-on experience working in an environment with a 21 CFR 820 (QSR) cGMP-compliant facility and processes.
  • Possess experience working with document control systems and/or eQMS software (i.e., Master Control, Greenlight Guru, Qualio, etc.)

SCHEDULE
This is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.

COMPENSATION & 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's Core Values
Ability to embody Geneoscopy's beliefs, philosophies, and principles:

• 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.

By completing this online employment application, you certify that the information on this application is true and complete to the best of your knowledge. You understand that any misrepresentation or omission of fact in response to any inquiry made in this application may result in the rejection of the application or if hired, dismissal whenever it is discovered. You authorize and release all parties from any liability or damage that may result from seeking, furnishing, or using such information. You understand and agree that, if hired, your employment is for no definite period and may, regardless of the date of payment of compensation, be terminated by Geneoscopy at any time, for any or no reason, with or without notice. You understand that no representation to the contrary is valid unless in writing, setting a definite term of employment, and signed by the company's CEO. You further understand and agree that any job offer is contingent upon your passing, to the company's satisfaction, a criminal background check, reference checks, and other possible screenings. You understand that this application is active for 90 days only, and if you do not hear from the company but still wish to be considered for employment after 90 days, you will need to fill out a new application.