Quality Assurance Specialist I

Geneoscopy, Inc.•Maryland Heights, MO

2d•Onsite

About The Position

The Quality Assurance Specialist I assists in ensuring that Geneoscopy's products and services meet the requirements of the Quality Management System while maintaining and managing the Company's document control system to ensure compliance with both the Clinical Laboratory Improvement Amendments (CLIA) and the Quality System Regulation (21 CFR 820). This is an onsite, in-office position at Geneoscopy HQ in St. Louis, Missouri.

Requirements

Bachelor's Degree required.
Possess at least 2 years of experience in a CLIA/CAP or QSR-regulated environment.
Possess hands-on experience working with document control systems and/or eQMS software (i.e., Master Control, Greenlight Guru, Qualio, etc.)
Possess strong attention to detail to ensure the accuracy and integrity of all documents managed.
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.

Nice To Haves

Hands-on experience working in an environment with a 21 CFR 820 (QSR) cGMP-compliant facility and processes.

Responsibilities

Assist in maintaining compliance with all applicable regulations and requirements (CLIA, CAP, NYS DOH, FDA, ISO, etc.).
Maintain the process for document control, including document creation, revision, and obsolescence.
Ensure documents are approved by the appropriate personnel in accordance with applicable policies and procedures.
Gather document requirements and details, ensuring documents are formatted in a consistent way and all aspects of the document control process are completed.
Maintain paper and electronic files so they are well-organized and easily retrievable.
Manage periodic document reviews to ensure adherence to internal procedures.
Assist users in navigating and effectively utilizing the electronic Quality Management System (eQMS).
Conduct training sessions for staff on the use and understanding of the eQMS as necessary.
Manage the document control module in the eQMS, including evaluations of updates and software validation as needed.
Participate in internal and external audits.
Coordinate quality processes.
Assist the Safety Officer with administrative safety tasks as necessary.
Participate in Management Review meetings.
Perform work under general supervision, navigating moderately complex issues and problems.
Exemplify solid working knowledge of the subject matter.
Other duties as assigned.