Quality Control Associate II (Molecular Diagnostic IVD)

Personal Genome Diagnostics

Baltimore, MD, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 05/14/2021
  • Website: personalgenome.com
  • Company Address: 2809 Boston Street Suite503, Baltimore, MD, 21224

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) is empowering 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.

Job Description

Personal Genome Diagnostics (PGDx) is seeking a detail-oriented and collaborative member to join our Quality Team. 

KEY RESPONSIBILITIES
  • Follow all ISO, cGMP/cGDP/cGLP, Environmental Health and Safety guidelines and regulations as required by the job function.
  • Perform manufacturing inspections, checks testing and sampling procedures for incoming components and raw materials to ensure that company standards are met
  • Under minimal supervision, performs routine and non-routine simple to complex testing in support of NGS finished and in-process products from manufacturing processes
  • Responsible for the testing execution for Test Method Validation protocols.
  • Collaborate with senior Associate and QC manager in periodical reviews of QC SOPs, final acceptance testing (FAT) protocols and quality batch records (QBRs).
  • Responsible to monitor critical equipment and instrumentation for proper operating condition to standards and assist with weekly and monthly lab maintenance and equipment log and calibration equipment.
  • Assist QC Management with the preparation and execution of QC investigations.
  • Participate and may coordinate all Lean Daily Management activities and support 5S initiatives and implementations.
  • Uphold the highest levels of safety performance in all aspects of the job.
  • Perform other duties related to the position when required by QC and Operations management.
  • Work with hazardous chemicals during the processing of QC samples.
  • Other duties as assigned
REQUIRED EDUCATION AND EXPERIENCE
  • BS in Biology/ Chemistry with 2-4 years of experience in molecular quality control OR Associates Degree in Biology/ Chemistry with 4-6 years of experience in molecular quality control.
  • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
  • Elisa testing and micro pipetting skills preferred.
  • MS Office Suite (Word, Excel, SharePoint) proficiency required.
  • NSG experience preferred.
  • 5S knowledge and experience with documentation practices preferred.
  • Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
  • 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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.