Quality Control Specialist

Caris Life Sciences•Phoenix, AZ

About The Position

The Quality Control (QC) Specialist- Incoming supports inspection of inventory reagents, R&D materials, consumables, finished goods, and kits sent to customers to ensure they meet required quality standards and regulatory guidelines. The role performs detailed inspections and evaluations against established specifications, company policies, industry regulations, and QC protocols. It also assists QC leadership with planning and conducting inspection activities in the laboratory and receiving area. The position requires periodic travel and may involve some evenings, weekends, and/or holidays. The individual must successfully complete the applicable pre-employment process, which may include a criminal background check, drug screening, credit check for certain positions, and reference verification.

Requirements

High school diploma and 1–2 years of experience in material management, quality control, or a related field.
Hands-on experience performing Incoming Quality Control inspections.
Working knowledge and understanding of Quality Systems, including document control, audits, and Management Review.
Ability to perform duties independently with minimal supervision in a regulated environment.
Strong written and verbal communication skills.
Ability to sit, stand, and/or work at a computer for long periods.
Visual acuity and analytic skill to distinguish fine detail, and ability to pass a visual color discrimination test.
Ability to lift up to 30 pounds.
Willingness to travel periodically and work some evenings, weekends, and/or holidays.

Nice To Haves

Associate or bachelor's degree.
Knowledge of FDA-regulated industry standards and regulations.
Willingness to learn and adapt to new processes and technologies.
Proficiency in Microsoft Office Suite, specifically Word, Excel, and Outlook, and general working knowledge of the Internet for business use.
Proficient verbal and written communication, willingness to share and receive information and ideas across organizational levels, and commitment to team and organizational goals.

Responsibilities

Inspect reagents, consumables, and R&D materials against established specifications and acceptance criteria for production processes.
Inspect manufactured products to verify components and labeling comply with applicable regulatory and quality requirements.
Inspect sample- and test-specific collection kits intended for customers.
Develop and maintain inspection methodologies, and create SOPs and job aides for inspection processes.
Initiate deviations in the eQMS when specifications are not met and participate in CAPA investigations related to materials.
Perform inspections and maintain timely, accurate records of results and related documentation.
Assist other QC functions with creating and maintaining documentation needed to comply with regulatory standards.
Collaborate with supply chain, quality assurance, and laboratory operations to meet business requirements while adhering to regulatory standards.
Work with cross-functional groups and supplier teams to address significant quality issues involving products or manufactured kits.
Coordinate with supplier quality teams to help develop vendor performance metrics aligned with quality standards and internal processes.
Identify and recommend opportunities to improve QC processes.
Assist in training new QC staff and support the team as needed.
Perform other duties as assigned.