QA Specialist

the Client•San Diego, CA

3d•Onsite

About The Position

The QA Specialist I performs quality testing and documentation activities for in-process, stability/calibration, final release, and experimental devices. The role is cross-trained across these processes, reviews device history records, helps resolve process-related questions and minor investigations, and trains new employees and Quality Control Technician I staff. The specialist operates laboratory equipment safely and maintains inventory of testing-related materials. The role supports the development, implementation, and effectiveness of the Alere Quality Management System in accordance with ISO, FDA, and other regulatory requirements. The specialist is expected to understand the quality consequences of improper job performance and remain aware of device defects that may arise in their area of responsibility, including in design, verification and validation, manufacturing, and testing. They carry out duties in compliance with business policies, maintain professional working relationships, and take on other duties as business needs change.

Requirements

High school diploma, GED, or equivalent.
2–5 years of relative work experience.
Proficiency with Microsoft Office Suite and strong knowledge of Excel.
Organized and detail-oriented.
Ability to work in a team environment.
Ability to multitask and adapt to changing task priorities.
Continually develop one's skill set.
Act ethically and take accountability for achieving outcomes.
Actively develop a network to bring the best solutions to the team or customer.
Applicants must be authorized to work for any employer in the United States; visa sponsorship or takeover of sponsorship is not available.

Nice To Haves

Bachelor of Science degree in a science-related field.
2–5 years of laboratory experience in quality control/assurance or a manufacturing environment, preferably in vitro diagnostics.

Responsibilities

Run in-process, stability/calibration, final release, and experimental device testing.
Notify appropriate personnel of results and complete associated data and documentation.
Cross-train on in-process, stability, calibration, and final release processes.
Resolve process-related questions and problems and conduct minor investigations.
Review device history records.
Train new employees and Quality Control Technician I staff.
Operate laboratory equipment safely, as trained and directed, and in accordance with established practices.
Maintain inventory of testing-related materials.
Support the development, implementation, and effectiveness of the Alere Quality Management System in accordance with ISO, FDA, and other regulatory requirements.
Understand quality consequences associated with improper performance and remain aware of device defects that may occur in the area of responsibility.
Exhibit professional behavior with internal and external business associates and build productive working relationships.
Carry out duties in compliance with established business policies.
Perform other duties as assigned based on changing business needs.