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- Review and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
- Oversee and review CMO batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with supply chain, warehouse, and quality control departments.
- Support the vector disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
- 4-7 years of relevant cGMP experience.
- Hands-on experience with material introduction and disposition is preferred.
- Knowledge of cGMP regulations and FDA, EU, ICH guidance applicable to biologics and cell therapy manufacturing/quality control.
- Strong computer skills with Word and Excel and other electronic manufacturing systems.
- Detail oriented team player with effective planning, organization, and execution skills.
QA Specialist - Seattle - ASK Consulting LLC

4 weeks ago

Description
Job Title: QA Specialist
A critical role within our Vector CMO Quality Assurance team is available for a highly skilled and detail-oriented QA Specialist. In this individual contributor position, you will be responsible for reviewing cGMP Controlled Documents, approving batch records, and managing the implementation of required changes to meet cGMP and internal standards.
Key Responsibilities:
Requirements:
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Contract Specialist
LHH- Seattle
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Intake Specialist
DESC- Seattle
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Electrophysiology Specialist
Unavailable- Seattle
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Billing Specialist
LHH- Seattle
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Caregiver Specialist
Full time Husky Senior Care- Seattle
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Benefits Specialist
Full time LHH Recruitment Solutions- Seattle
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Inventory Specialist
Amazon- Seattle
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Purchasing Specialist
SuperGraphics- Seattle
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Peer Specialist
DESC- Seattle
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Reservation Specialist
Happy Vibes Travel- Seattle
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Compliance Specialist
LHH- Seattle
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Payroll Specialist
LHH Recruitment Solutions- Seattle
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Residential Specialist
Full time Plymouth Housing Group- Seattle
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Farm Specialist
Earthcorps- Seattle
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Benefits Specialist
Full time Shannon & Wilson Inc- Seattle
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Furniture Specialist
Full time ZGF Architects- Seattle
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Security Specialist
Seattle Children's- Seattle
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IT Support Specialist
Full time Blue Star Partners LLC- Seattle
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Design Specialist
Apple- Seattle
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Hoarding Specialist
Full time Downtown Emergency Service Center- Seattle
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infrastructure specialist
University of Washington- Seattle