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QA Specialist - II

Company: Mindlance
Location: Santa Monica
Posted on: January 10, 2022

Job Description:

Job Description -Qualifications:
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
Evaluates supplier qualification requests from cross-functional partners and initiates supplier qualification and supplier scope expansion activities.
Supports qualification of suppliers using risk-based approach through questionnaires and audits.
Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, forms, etc.) as needed to ensure defined quality objectives are met.
Execute and maintain quality agreements for suppliers.
Assesses suppliers for additional qualification activities due to commodity scope change.
Supports Supplier Quality Performance Monitoring/surveillance activities.
Participates in Supplier Corrective Action Request (SCAR) process.
Facilitates supplier notifications (supplier initiated changes) and perform impact assessments from supplier changes.
Discontinues or disqualifies GxP suppliers based on quality and business needs.
Support the selection of GxP suppliers with Sourcing through due diligence activities and product quality team assessments.
Provides quality approvers for change controls related to SICs.
Participates in health authority (FDA/EMA, TGA) inspections.
Manages supplier qualifications for new product and new technology projects and new manufacturing site start-ups, including planning, tracking and status updates.
Represents supplier quality on cross-functional teams for new products, technologies, and sites.: 21-70151 : Santa Monica, CA:

Keywords: Mindlance, Santa Monica , QA Specialist - II, Other , Santa Monica, California

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