СШАQuality Control Specialist I (Contractor)
1 нед. назад
СШАJuniorOnsite
ngsdocumentationquality controlmethod validationdata analysis
Perform reagent quality control testing and support quality control processes in a CLIA laboratory setting for early cancer detection.
О компании
- At , we are seeking a Quality Control Specialist I to help grow the Quality Control team within the Lab Operations Department. The ideal candidate is experienced in Next-Generation Sequencing (NGS) workflows, detail-orientated, and familiar working within a CLIA laboratory setting. This person will perform reagent quality control testing, author and maintain documentation, support method tech transfer, and perform tracking and trending of QC data. You are passionate about contributing to developing life-saving diagnostics through early cancer detection, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.
- The role reports to the Quality Control Supervisor. This role will be an onsite role based in our Brisbane, California headquarters.
Обязанности
- Perform reagent quality control testing per Standard Operating Procedures
- Author, review, and maintain documentation, such as Standard Operating Procedures, Work Instructions, QC Records and Forms for regulatory compliance
- Initiate non-conformances for any process deviations or reagent quality control failures
- Participate in the investigation of 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
- Build and maintain strong knowledge of fundamentals and regulatory requirements applicable to laboratory operations and quality control
Требования
- Bachelor’s degree in Chemistry, Biochemistry, Biology, Bioengineering or similar field
- Ability to follow written procedures and work in a regulated environment
- Ability to complete documentation in an accurate and timely manner in order to maintain regulatory compliance
- Strong attention to detail and time management skills
- Excellent interpersonal and communications skills in order to work in a highly cross-functional environment
Будет плюсом
- Experience with performing routine laboratory equipment maintenance
- Hands-on experience with automated liquid handlers (e.g., Hamilton, Bravo)
- Proficiency with Microsoft Excel, Word, and PowerPoint
Другое
- Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ .com/job-openings/ for additional company information.
- Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Employee Polygraph Protection Act (EPPA)
- California applicants please review the CCPA Notice at Collection here:
- California Consumer Privacy Act (CCPA)
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