2 часа назад
Quality Control Specialist II (NGS)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Specialist II (NGS): Performing reagent quality control testing and maintaining regulatory documentation for a CLIA laboratory developing early cancer detection diagnostics with an accent on NGS workflows, GMP/ISO compliance, and QC data analysis. Focus on investigating reagent failures, supporting QC method tech transfer and validation, and maintaining reliable laboratory processes and records.
Location: Onsite in Brisbane, California, United States
Company
develops life-saving diagnostics focused on early cancer detection.
What you will do
- Perform reagent quality control testing according to Standard Operating Procedures.
- Author, review, and maintain Standard Operating Procedures, Work Instructions, QC Records, and Forms.
- Initiate non-conformances and investigate reagent and consumable quality issues.
- Record, analyze, and trend QC data using good documentation practices.
- Support the tech transfer and validation of QC test methods to GMP standards.
- Maintain knowledge of laboratory operations and quality control regulatory requirements.
Requirements
- Bachelor’s degree with at least two years of relevant experience, or a Master’s degree, in Chemistry, Biochemistry, Biology, Bioengineering, or a similar field.
- Knowledge of Quality Control and Quality Assurance principles, including GMP and ISO.
- Technical writing experience with laboratory procedures, work instructions, QC records, and forms.
- Hands-on experience with automated liquid handlers such as Hamilton or Bravo.
- Experience performing routine laboratory equipment maintenance.
- Exceptional attention to detail, high-quality data practices, and strong interpersonal and communication skills.
Nice to have
- Experience maintaining 5S workplace organization principles in a laboratory.
- Experience with LIMS, Netsuite, SoftMax Pro, or Bartender.
- Proficiency with Microsoft Excel, Word, and data analysis tools.
Culture & Benefits
- Onsite work at the Brisbane headquarters.
- Collaboration with the Quality Control team within Lab Operations and adjacent disciplines.
- Contractor engagement may be arranged through a third-party provider, with contingent worker status.
- Equal opportunity workplace committed to diversity.
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