QA Shop Floor Specialist
2 weeks ago
Schedule- 9:00pm - 7:30am, Sun - Wed
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 Bothell Manufacturing Plant (Jump). 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.
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.
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 Associates 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 is 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.
Additional Job Requirements:
Lab w/ blood & animal
The hourly rate for this position is between $40.00 - $42.00 per hour.
Compensation:
Factors that may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate .
Benefits:
Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
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