Kelly Services Quality Assurance Specialist II, Change Control & Batch Record Review in Seattle, Washington

Kelly Scientific is looking for a Quality Assurance Specialist II to join a biotech company based in Seattle, WA. This individual will be primarily working with change control and batch record review. The Quality Specialist is responsible for supporting the maintenance of the Quality Management System (QMS) with a primary focus on Electronic Document Management System (EDMS) Change Control and Batch Record/DHR review. Responsibilities include implementing changes to Development, Production, Manufacturing Operations, and Engineering controlled documents, parts and Bill of Materials (BOM); ensuring that all changes are accurate and performed on schedule; disseminating updated information; and maintaining a record of all changes. The Quality Specialist initiates and implements quality improvement activities as appropriate.

Essential Duties:

  • Provides guidance, support and mentorship to related to document control.

  • Performs Batch Record/DHR review; assists in quality records management.

  • Processes change packages including verifying correct information is in packages, formatting and proofreading quality documents.

  • Conducts training for MasterControl, Creator, revisers as needed.

  • Compiles monthly/quarterly metrics.

  • Maintains Quality Records in applicable format.

  • Provides guidance for employee’s regarding document control processes.

  • Supports training file and program management and training records database.

  • Supports ongoing Quality Assurance monitoring and document proofreading and editing functions for consistent terminology, structure and format, as needed.

  • Provides support for quality system activities, as needed.

Requirements:

  • Minimum BS degree in quality or science (chemistry, biology or medical technology) or related field.

  • 2-3 years related experience in regulated industry (Medical Devices; IVD preferred).

  • Strong computer skills including Microsoft Office, QA applications and databases.

  • Knowledge of tools, concepts and methodologies of QA.

  • Adequate exposure to medical device regulatory requirements, 21 CFR Part 820 and ISO 13485.

  • Demonstrated verbal and written communication skills.

  • Ability to multi-task, work independently and in a team environment.

  • Excellent analytical skills.

  • Demonstrated ability to handle highly confidential information appropriately.

Apply Today!

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.