Job Title: QA Shop Floor Specialist
Job Location: Bothell, WA
Job Duration: 6 Months+
Schedule- 9:00 pm - 7:30 am, Sun - Wed
Pay range: $40 - $43/hr. on W2
Top Skills:
3-5 years of GMP work experience
Familiarity with Batch Records
Deviations Experience Preferred
Associates or BA Degree preferred, or HS Diploma + relevant work experience
Soft skills include- strong cross-functional experience, strong interpersonal skills
Job Description:
The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Client.
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 Client's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Client with an emphasis on supporting Manufacturing with a Quality on-the-floor presence within a regulated cGMP environment.
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 Client by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications.
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.
Education:
Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of associate degree and/or equivalent combination of education and experience is required.
• 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are preferred.
• Hands-on experience with batch record review and product disposition is preferred.
• 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.
• Proven experience working on teams where combined contribution, collaboration, and results were expected.
• Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
• Ability to work in a high paced team environment.
• Strong written and verbal skills.