Quality Assurance Specialist II

Quality Assurance Specialist II

This is a hybrid position based at Geneoscopy HQ in St. Louis, Missouri.

This position assists in ensuring that Geneoscopy's products and services meet the requirements under the Quality Management System.

• Assist in maintaining compliance with all applicable regulations and requirements (CLIA, CAP, NYS DOH, FDA, ISO, etc.).
• Own and manage one or more major processes under the Quality Management System.
• Support the Quality Management System, including document and record control, nonconformances, customer complaint processes, training processes, internal and external audits, and other work under the QMS as needed.
• Conduct gap analyses and best practice reviews to sustain and continually improve the Quality Management System.
• Implement new and maintain procedures and/or controls to achieve regulatory compliance and operational efficiency.
• Review records for accuracy.
• Coordinate quality processes.
• Participate in Management Review meetings.
• Perform work under minimal supervision, navigating complex issues and problems.
• Exemplify solid working knowledge of the subject matter.
• Provide coaching and/or mentoring to others.
• Other duties as assigned.

• Bachelor's degree required.

• Possess 3+ years' experience in a CLIA/CAP or QSR/QMSR regulated environment.
• Knowledge of regulated processes.
• 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.

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

• 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.
• Company stock options

• 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

• 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.

• May have exposure to fumes and bio-hazardous material in the laboratory environment.
• May be required to handle blood-borne pathogens and general laboratory reagents.