Sr. Quality Specialist

Location: Sunnyvale, California, United States
Salary: competitive
Job Type: Contract
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Sr. Quality Specialist - Biotech Industry Company - Sunnyvale

The ideal candidate would overall be responsible for reviewing quality agreements, Master Service Agreements and Scope of Work Documents to make sure that the client quality expectations are clearly aligned with Quality Systems.

Responsibilities:

· Manages the review and execution of client Quality agreements

· Collaborates with internal management team to ensure that all departments are aware of compliance requirements and issues

· Supports the Associate Director in leading gap assessments of Quality Systems against current US and international regulations

· Facilitates the review and approval of deviation reports; ensures appropriate corrective actions are assigned and closed; and prepare and present metrics for issue management

· Leads performance of GMP gap assessments of quality systems and associated improvement plans

· Reviews quality systems to identify gaps and improve quality systems to support commercial manufacturing of vectors and cell therapy products

· Act as client liaison to monitor client commitments, provide updates at product team meetings and manage progress of commitments to support Operations and Project Management Team

· Provides training and guidance on quality agreements

· Coordinates completion of issue management and CAPA closure

Sthree US is acting as an Employment Business in relation to this vacancy.

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