Quality & Regulatory / Baltimore, Maryland

CLIA Quality Assurance II

Key Responsibilities

  • Lead QA functions for CLIA/CAP lab and assist with IVD QA as required.
  • Participate in the resolution of pre-examination, examination and post-examination specimen CLIA lab issues and CAPA review and resolution.
  • Assist with deviations, CAPA and Quality Events.
  • Ensure compliance with the CLIA Lab Quality Assurance Program.
  • Oversee and manage records related to conducting review and assessments of equipment maintenance and calibration.
  • Serve as Quality representative for CLIA/CAP related Quality Events/​CAPAs and clinical research projects.
  • Lead quality audits of laboratory operations, document audit findings, and report results to senior leadership.
  • Perform required duties in compliance with CLIA, OSHA, CAP, New York State, California State, FDA and other laboratory regulatory authorities.
  • Participate in cross-functional laboratory quality projects.
  • Conduct internal audits, critical phase inspections and vendor audit/​assessments.
  • Promote a mindset of quality and continual process improvement.
  • Write, review, and revise CLIA related policies, protocols, and procedures.
  • Maintain familiarity with CLIA and CAP regulations.
  • Perform related duties as assigned by supervisor
  • Maintain compliance with all company policies and procedures

Required Education & Experience

  • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
  • Excellent computer proficiency (MS Office – Word, Excel and Outlook)
  • Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
  • Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices
  • 2 — 4 years of experience in CLIA Quality Assurance Role
  • Prior lab experience in a molecular diagnostic setting highly preferable
  • BS in biology or related field

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
  • Must be able to lift and carry up to 50 lbs

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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