Quality & Regulatory / Baltimore, Maryland

Quality Assurance Analyst II

Key Responsibilities

  • Review and release manufacturing batch records for hardware, reagent vialing, and kitting records (including manufacturing build sheets, disposition forms, and other production records)
  • Oversee material release: quarantine materials, inspects shipments, examines certificates of analysis, review test results, and determines/​approves release status
  • Maintain organization and storage of archived manufacturing records
  • Assist with the implementation and maintenance of eQMS
  • Assist in coordination of internal and external audit preparation
  • Assist in the management of equipment and maintenance records
  • Administer Quality Assurance portion of New Hire Orientation training
  • Assist with procedures, compiling documents as directed, and other quality management tasks as assigned
  • Perform related duties as assigned by supervisor
  • Maintain compliance with all company policies and procedures
  • Reports to Design Quality Manager

Required Education & Experience

  • Bachelor’s degree in biology or science related field
  • Able to prioritize many tasks
  • Independent
  • Basic knowledge of scientific terms and basic procedures
  • Ability to learn quickly and operate under a fast busy work pace
  • Familiarity with ISO 13485:2016, FDA or IVDR regulation is preferred

Physical Requirements

  • Ability to safely and successfully perform the essential job functions consistent federal, state and local standards, including meeting qualitative and/​or quantitative productivity standards

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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