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The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the BMS Jump site, including the coordination, issuance, reconciliation, and management of production labels and records.
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Strong computer skills with MS Office (e.g. Word, Adobe, Kofax, Smartsheet, Visio and Excel) and with Quality Systems (e.g. Records Management System, Quality Management System). Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
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The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). 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.
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The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant. This role directly supports Jumps 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 Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.
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Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP. 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.
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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.
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Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and managing the implementation of required changes to meet cGMP and internal standards.
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Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
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Performing tasks in a manner that are consistent with departmental and corporate safety policies, quality systems, and GMP requirements. Distribution, receiving, temperature storage, issuance, and inventory control practices including cycle counting, and rejected/expired material disposition.
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The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Client. 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.
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Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and managing implementation of required changes to meet cGMP and internal standards.
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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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Support change control initiatives as applicable. 3-5 years of relevant cGMP experience. Title - Quality GMP Specialist. Hands-on experience with batch record review and product disposition is preferred.
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This individual will join the Quality Control leadership team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. As the QC Stability and Sample Management Manager, you will be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Just-Evotec.
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cgmp quality control jobs in Redmond, WA
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