Hybrid QA Compliance Specialist II — Regulated Lab

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

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.