Quality Assurance Technician

Actalent•Austin, TX

36d•$20 - $25•Onsite

About The Position

The Quality Assurance Technician participates in the design, creation, implementation, and monitoring of programs and methodologies to ensure that company products meet established specifications, design criteria, quality standards, and customer requirements. The primary function is to support the product release department by reviewing device history/batch records for compliance with internal procedures. This individual will ensure that the requirements for product release are met, focusing on enhancing throughput for the Product Release Department.

Requirements

Experience in quality assurance, CAPA, and audit processes.
Must have experience in an FDA-regulated environment (pharma, med device, biotech).
1+ year of experience in a manufacturing environment.
1+ years of experience in Quality (QA preferred, but QC considered).
Proficiency in computer skills, including Microsoft Windows and Office programs.

Nice To Haves

Experience in a fast-paced environment with the ability to switch between tasks quickly.
Experience with Oracle.
Certification in Quality discipline (CQT, CCT, CQI, etc.).
1+ years of experience participating in formal audits.
An Associate's Degree in engineering or life sciences is preferred.

Responsibilities

Review device history/batch records for compliance with internal procedures.
Ensure that product release requirements are met.
Provide information for metrics tracking systems, including the number of reviews conducted and errors identified.
Communicate issues to the floor and coordinate necessary corrections.
Negotiate actions to be performed to address identified issues.