Quality Control Specialist I

Geneoscopy, Inc.•Maryland Heights, MO

1d•Onsite

About The Position

The Quality Control (QC) Specialist I is responsible for performing quality control activities related to medical records and other quality documentation throughout the testing and manufacturing lifecycle. This role ensures accuracy, completeness, and compliance with internal procedures, regulatory requirements, and quality standards. The QC Specialist I reviews and verifies records, identifies discrepancies, and supports timely resolution to maintain data integrity and product quality. This position collaborates cross-functionally with laboratory, manufacturing, and quality teams to support efficient operations and continuous improvement within the quality management system.

Requirements

Possess 1-2 years of experience in a CLIA/CAP or QSR-regulated environment.
Possess a minimum of 2 years of PCR testing experience.
Demonstrate the ability to read and understand technical procedures and instructions.
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

A degree in Biology or Chemistry is ideally preferred.

Responsibilities

Conduct QC reviews of sample/specimen data for accuracy throughout the testing process.
Help to provide assurance of the quality of our products by evaluating incoming materials, inspecting components and products at various stages, and evaluating the functionality of finished products using ddPCR.
Support the laboratory and clinical operations, performing QC checks as needed on data and manual entries.
Collaborate with laboratory personnel to update or open nonconformances for inaccurate data.
Track and trend QC data and prepare quality presentations.
Assist in maintaining compliance with all applicable regulations and requirements (CLIA, CAP, NYS, DOH, FDA, ISO, etc.).
Support the Quality Management System, including but not limited to nonconformances and customer complaint processes.
Conduct gap analyses and best practice reviews to sustain and continually improve the Quality Management System.
Participate in internal and external audits and manufacturing inspections.
Review incoming material release inspections.
Navigate and execute laboratory equipment inspections.
Review, revise, author, and implement new procedures and/or controls to achieve regulatory compliance and operational efficiency.
Perform work under general supervision, navigating through moderately complex problems.
Exemplify solid knowledge of the subject matter.
Other duties as assigned.