Manufacturing Quality Lead
JOB DESCRIPTION

The Manufacturing Quality Lead will provide a broad scope of technical knowledge in processes such Raw Material Disposition, Batch Record Review and Disposition, Factory Acceptance Testing Record Review, Nonconforming Product Investigations and Material Review Boards.  The Quality Lead will  support and maintain a QMS that adhere to,  GMP (QSR 820) regulation, ISO 13485:2016 and other standards/ governing regulations applicable to PGDx.

KEY RESPONSIBILITIES
  • Lead the prioritization and coordination of batch release activities, to prevent supply disruption.
  • Oversee raw material release: quarantines materials, inspects shipments, examines Certificates of Analysis, reviews test results, and determines release status.
  • Train new and existing employees on Lot Disposition and Quality System processes.
  • Performs quality review and approval of Quality Events in the eQMS for internal discrepancies associated with Kit Quality Release and ma Operations processes and plasma supplier discrepancies; oversee investigations and approves corrective/preventative actions.
  • Provide guidance to team in resolution of Product nonconformance.
  • Mentor employees in investigation techniques and tools.
  • Conduct trend analysis of Batch Release metrics.
  • Participate in CAPA Review Board activities.
  • Conduct process audits to ensure activities and documentation conform to standard operating procedures and regulatory requirements.
  • Actively participate in internal audits as and support the closure of audit observations within the specified timeframe.
REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s Degree in Engineering or Science
  • Minimum of 4 years in IVD medical device or ISO 13485 manufacturing within Quality.
  • Versed in ISO 13485:2016,  21CFR Part820 and 21CFRPart 11
ABOUT PERSONAL GENOME DIAGNOSTICS

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@personalgenome.com Special consideration will be given to internal PGDx employees who apply.

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