Senior Quality Control Specialist

    • Job Tracking ID: 170120
    • Job Location: Seattle, WA
    • Job Level: Mid Career (2+ years)
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: September 22, 2017
    • Years of Experience: 5 - 7 Years
    • Starting Date: ASAP
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Job Description:

ARE YOU ADAPTIVE? We’re driving groundbreaking research in cancer and other immune-mediated diseases that translates into novel clinical diagnostics and innovative therapeutics. We are at the forefront of immune-based discoveries, transforming the future state of health through our disruptive, proprietary immunosequencing technology. With strong financial footing and rapid growth, we are looking for the brightest, most passionate and collaborative innovators to join us.

At Adaptive, you'll be challenged, you'll be inspired, and you'll be proud to be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you'll find a diverse, team-driven, fun culture where your contributions truly count. #BeingAdaptive

 

 

Position Overview:

The Senior Quality Control Associate is responsible for implementing and maintaining the activities of quality control systems. The position works with technical staff to develop and implement standards, methods, and procedures for inspecting, testing, and evaluating the compliance of next generation sequencing related company products to established specifications. QC also evaluates and implements protocols and methods to inspect and test raw materials, in-process and finished products. Performs analysis and interpretation of test results, identify deviations, and makes appropriate recommendations. Performs product stability testing, prepare relevant protocols and reports. Revises and updates standard operating procedures as needed. Participates in methods and equipment qualification/validation studies; generates protocols, executes and coordinates experiments, and drafts reports.

 

 

Job Responsibilities:

  • Author, edit, review, and approve quality control related policies, procedures and test methods in compliance with global regulatory requirements, including FDA and ISO
  • Participate in development of test methods for existing and new products in collaboration with Research and Development and contract manufacturers
  • Test method validation activities: prepare validation plans, protocols and reports. Execute on protocols
  • Product stability: prepare protocols, reports and perform testing
  • Review data for compliance to specifications; document and investigate nonconformities
  • Lead investigations of laboratory deviations and OOS/OOT results
  • Good Documentation Practices of testing and laboratory procedures

 

Experience and Skills:

 

 

Required Experience:

  • Bachelor’s degree in a relevant scientific discipline is required; Master’s degree highly desired
  • Must have 5+ years demonstrated quality control experience
  • Recent strong experience in quality control in FDA regulated industry required
  • Expert in method development and transfer preferred
  • Experience in assay qualification and validation strongly desired
  • Laboratory experience with a variety of analytical techniques including, but not limited to, quantitative PCR, high throughput sequencing, nucleic acid preparation methods
  • Knowledge of statistical methods applicable to the analysis of experimental data
  • Proficient in general and non-routine laboratory skills
  • Strong working knowledge of FDA and ISO good manufacturing practices (cGMPs)
  • Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
  • Demonstrated ability to develop, communicate and influence solutions to complex problems
  • Exercises judgment within well-defined and established procedures and practices to determine appropriate action
  • Ability to work independently and in a team environment
  • Detail-oriented with good organization and time management skills
  • Strong interpersonal and verbal/written communication skills required
  • Able to respond quickly to shifting priorities and to meet deadlines

 

 

Preferred Experience:

  • Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories is highly desirable
  • Hands-on experience in NGS platform, such as Illumina sequencers
  • Experience in LIMS and automation system for assay execution
  • Excellent problem-solving and analytical skills
  • Ability to change focus within short notice

 

 

Salary is commensurate with experience and qualifications. Excellent benefits package including employer paid medical, dental, vision, vacations and holidays for eligible positions.

Adaptive Biotechnologies Corp. is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.