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Position Details:
Job Title: QA Shop Floor Specialist
Location: Bothell, WA, 98021
Duration: 6 Months Contract
Job Description
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.
ROLES AND RESPONSIBILITIES:
Job Type: Contract
Pay: $35.00 - $40.00 per hour
Benefits:
Schedule:
Work setting:
Education:
Experience:
Ability to Relocate:
Work Location: In person
Contractor
IT Outsourcing & Consulting
$103k-123k (estimate)
05/13/2024
05/18/2024
fortira.com
PRINCETON, NJ
50 - 100
1996
CHRIS KAMBHAMPATI
$5M - $10M
IT Outsourcing & Consulting
At Fortira, we completely understand that each of our customer's needs are different and our solutions are just that- Tailor-made for you. Customisation with minimum cost but maximum success is the defining goal of each of our services. Our certified professionals are trained to translate your complex hardware, software and network environments into effective business processes and help you in deriving optimum returns on your investments. Although we deal with some of world's most reputed and largest companies, but your size quite honestly is the last thing on the back of our minds. With a sha...rp eye on delivering quality and adept at cross-technology methods, a challenging situation is what we aspire for and our services will change the way you do business. We believe in deploying robust business applications as soon as we possibly can, working around the clock in an efficient way. Our wide range of service offerings, we believe will help you in making the most of your IT investments. Services : Near Shore Services. Infrastructure Management, Technology, Consulting, Life Sciences Vertical, DevOps Consulting Services, Azure Consulting Service, Microsoft Dynamics ERP and CRM, Software Solutions, Mobile App Development.
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