Specialist, Quality Assurance Operations - Bothell, WA, United States - Yoh

Description

QA Floor Specialist

6 month W2 contract (with potential to extend or transition to perm)

Pay rate:
$38-42hour - Depending on Education and Experience

The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump).

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Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards.

This role directly supports Jump's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Jump with an emphasis on supporting Manufacturing with a Quality on-the-floor presence within a regulated cGMP environment.

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The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations.

Assist the QA department in maintaining the Quality focused culture at Jump by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications.

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The QA Specialist primary role is on-the-floor and contributes with off-the-floor projects and activities that are just as significant as on-the-floor work.

Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP.

Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.

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Oversee manufacturing operations from patient material receipt to drug product pack out.??
May support internal and external audits, including documenting observations.
Identify and facilitate continuous improvement projects.
Revise Standard operating Procedures as needed, and review/approve document revisions.
Drives right first time (RFT) by providing direct training, guidance, and problem solving to peers.
Provide training, coaching, and feedback for GMP guidance.

Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation.

Strong computer skills with Word and Excel and other electronic manufacturing systems.??
Detail oriented team player with effective planning, organization, time management and execution skills.??
Bachelor's degree in relevant science or engineering discipline is preferred.
~ Yoh's network of client companies has been employing professionals like you for over 65 years in the U.Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
~ Medical, Dental & Vision Benefits
~401K Retirement Saving Plan
~ Life & Disability Insurance
~ Direct Deposit & weekly ePayroll
~ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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