Quality Assurance Specialist II

Geneoscopy, Inc.•Maryland Heights, MO

2d•Hybrid

About The Position

This position assists in ensuring that Geneoscopy's products and services meet the requirements under the Quality Management System. This is a hybrid position based at Geneoscopy HQ in St. Louis, Missouri.

Requirements

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.

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.