Quality Assurance Specialist II

Geneoscopy; Maryland Heights (MO); Hybrid; USD 65,000 - 85,000; Full time

Benefits offered by this job

Health insurance & vision & dental

Life insurance

401k with employer match

Paid time off

Company stock options

Job summary

Geneoscopy in St. Louis, MO, is seeking a Quality Assurance Specialist II for a hybrid schedule based at our HQ. The role ensures our products and services meet Quality Management System requirements and regulatory standards.

You will own major QMS processes, maintain documentation, manage audits, and drive continuous improvement, with collaboration across teams and coaching responsibilities.

Qualifications

• 3+ years in a CLIA/CAP or QSR/QMSR regulated environment.
• Knowledge of regulated processes.
• Ability to multitask in a fast-paced, deadline-driven environment.
• Proficient verbal and written communication skills.
• High ethics; conduct business professionally.
• Seek inclusiveness and collaboration; take responsibility and be accountable for decisions.
• Team-player with strong interpersonal and communication skills.

Responsibilities

• Assist in maintaining compliance with CLIA, CAP, NYS DOH, FDA, ISO, etc.
• Own and manage one or more major QMS processes.
• Support the QMS, including document/record control, nonconformances, audits, and training processes.
• Conduct gap analyses and best-practice reviews to improve the QMS.
• Implement new procedures to achieve regulatory compliance and efficiency.
• Review records for accuracy.
• Coordinate quality processes.
• Participate in Management Review meetings.
• Perform work with minimal supervision on complex issues.
• Provide coaching and mentoring to others.
• Other duties as assigned.

Skills

Regulatory experience

Regulated processes

Multitasking

Verbal & written communication

Ethics

Collaboration

Decision accountability

Education

Bachelor's degree

Job description

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.

RESPONSIBILITIES

• 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.

EDUCATION REQUIREMENTS

• Bachelor's degree required.

QUALIFICATIONS

• 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.

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.
• Company stock options

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.

Work Environment

• 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.