Quality System Specialist I
Woodinville, WA

Job Description

Overview

The Quality Systems Specialist will perform activities related to Learning Management System (LMS), Quality Notifications, CAPAs and Effectiveness Checks within the QMS.

Responsibilities

This position will perform activites related to Learning Management System, Quality Notifications, CAPAs and Effectiveness Checks within the QMS. Various QMS tracking, data entry assignments. Reviews and compiles device history records for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements. Documents deviations as appropriate. May perform activities related to one or more quality assurance functions including batch record review, product release, assisting with document inquiries and retrieval of archived documents and records, electronic records, SAP transactions, and posting of CofAs. Maintain and archive controlled documentation and completed quality records. Provides support during external audits or inspections. Administers investigation and deviation systems for tracking status, follow-up and liaison with applicable department investigation writers. Works with operations personnel to continually improve quality procedures and methods. Assists with supporting internal and external audits and investigations. Analyzes and prepares data for reports and recommendations for management reviews. Assists with Quality System projects as necessary. Supports databases and systems used for tracking various QMS activities. Supports and execute Document Control and ECR/ECO change processes.

Qualifications

Education: High School diploma or equivalent. Associate degree in Biology, Chemistry, or related field preferred.

Experience: 0 - 2 years of relevant experience in document creation and managing Document Control functions within a document management systems and product life cycle systems. Strong technical writing background is a plus.

Skills:

* Preferred candidates should have experience working under FDA regulations and ISO standards.
* Good organizational skills, including the ability to manage multiple projects simultaneously, with follow-through and ability to meet defined deadlines.
* Strong interpersonal skills are necessary to operate in a team environment to interact with multiple departments under a variety of conditions
* Microsoft Office applications including Word and Excel are required. SAP, PowerBI and Visio experience is a plus.
* Formal training that demonstrates a possession of and competency in the requisite knowledge, skills, and abilities to successfully perform the duties and responsibilities of this position.

What's in it for you?

Competitive pay and great benefits including medical, dental, vision, 401K, and more!Opportunities for growth and training. Stability of a profitable 60+ year old company. Great work environment.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.