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PDS Tech Inc Local Quality Expert (Mid)-Quality Production-QUAL-PH-US in Berkeley, California

PDS Tech, Inc. is seeking a Local Quality Expert Berkeley, CA

Job Summary:

  • Support key supplier quality management processes to ensure quality materials and services are used to manufacture safe and compliant product.

  • Key activities could include supplier assessment/evaluations, supplier audit / audit program management, supplier qualification, quality assurance agreements, supplier change notifications and raw material specifications.

Drive at least one of the following:

  • Drive the Supplier Qualification program; publish the approved supplier list, create and manage records in the qualification database, perform research and compile supplier qualification packets.

  • Drive the Supplier Change Notification evaluation program; manage the supplier notification inbox and associated tracking system, perform initial screening and evaluations of notifications, process changes in the relevant change control systems based on notification impacts, and track metrics associated with evaluation and record processing.

  • Drive the Material Specification program; draft new specification documents and review technical content, provide oversight for the specification document management system, partner internally and negotiate with suppliers to approve specification documents, obtain internal/external approval for specification documents and upload to SAP.

Support the following activities:

  • Support the supplier qualification program; perform research on supplier backgrounds and compile qualification packets, access and update records in the relevant qualification databases and provide feedback to requestors on qualification documentation.

  • Support the supplier documentation program; perform QAA risk assessments, field questions about QAA content and support QAA amendment process, route new Raw Material Specification documents internally and externally to obtain approval, upload approved specification documents to SAP, and perform review of specification documents against the supplier certificates.

  • Support the supplier change notification program; perform initial screening and evaluations of notifications, process changes in the relevant change control systems based on notification impacts.

Other tasks should include:

  • Support data gathering and compiling for monthly reports for SQMR, APR and/or SMF.

Minimum Education and Experience Requirements:

  • Bachelor’s degree in a scientific/ technical field or equivalent experience.

  • Preference for CSQP, CQA or CMQ/OE

  • Minimum 6 years of Quality or Manufacturing In pharmaceutical operations, preferably biotech

  • Equivalent experience in combination with an MS 2+ years or PhD 1+ years

  • External Audit experience preferred

  • Understanding and experience in Supplier Qualification knowledge of GMP

  • Proven ability as a team player

  • Excellent interpersonal skills

  • Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations.

  • The ability to multitask and support changing priorities

  • Strong written and oral communication skills, good presentation and influencing skills

  • Strong ability to plan and prioritize conflicting objectives to meet various goals under different SQM programs

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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