Quality Assurance Specialist II

Geneoscopy; St. Louis (MO); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

401k with employer match

Paid time off

Company stock options

Job summary

Geneoscopy is seeking a Quality Assurance professional to ensure our products and services meet Quality Management System requirements. This hybrid role at our St.

Louis HQ involves maintaining regulatory compliance across CLIA, CAP, FDA, ISO, and other standards, while owning major QMS processes and supporting audits and records control. The role requires a Bachelor's degree and 3+ years in a regulated environment, with strong communication and team collaboration skills to drive continual

Qualifications

• Bachelor's degree required.
• 3+ years' experience in a CLIA/CAP or QSR/QMSR regulated environment.
• Ability to multitask and work in a fast-paced, deadline-driven environment.
• Strong verbal and written communication skills.

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 QMS, including document and record control, nonconformances, customer complaint processes, training processes, audits, and other QMS work.
• Conduct gap analyses and best practice reviews to sustain and improve the QMS.
• Implement new/maintain procedures to achieve regulatory compliance and operational efficiency.
• Review records for accuracy.
• Coordinate quality processes.
• Participate in Management Review meetings.

Skills

Regulatory compliance

Quality management

multitask

Communication

Team collaboration

Education

Bachelor's degree

Job description

Pay Type: per year Benefits: Benefits include health, vision, dental, life insurance, 401k (with employer match), and paid time off.

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 but not limited to 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

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.


• 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.