Manager, Quality Control

    • Job Tracking ID: 170120
    • Job Location: Seattle, WA
    • Job Level: Management
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: March 12, 2018
    • Years of Experience: 5 - 7 Years
    • Starting Date: ASAP
Invite a friend
facebook LinkedIn Twitter Email

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 Quality Control Manager is a key member of the quality systems team and is responsible for implementing and maintaining the activities of quality control systems and leadership of QC team.  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 and services to established specifications.  Evaluates and implements protocols and methods to inspect and test raw materials, in process and finished products.  Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations.  Oversees product stability testing, preparation of relevant protocols and reports.  Revises and updates standard operating procedures as needed.  Oversees preparation of protocols for QC methods and equipment qualification/validation studies, execution of studies and report preparation.



Job Responsibilities:

The Quality Control Manager is responsible for the day-to-day management of the Quality Control staff and the implementation of quality control procedures and plans, key responsibilities include:

  • Establishing and maintaining quality control related policies, procedures and test methods in compliance with global regulatory requirements, including FDA and ISO 13485 
  • Coordinating QC activities, ensuring quality control in accordance with the requirements of standard operating procedures (SOPs), protocols and product development specification documents
  • Participation in development of test methods for existing and new products in collaboration with R&D, Operations and contract manufacturers
  • Test method validation activities: prepare validation plans, protocols and reports.  Oversee execution of protocols
  • Preparation and execution of product stability studies, including protocol and report preparation and ongoing 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
  • Represent QC on product development teams


Experience and Skills:

Required Experience:

  • BS/MS/PhD in Chemistry, Pharmaceutical Sciences, Analytical Sciences or closely related scientific discipline is required, advanced degree preferred
  • BS/MS with 3-5 years or PhD with 2-3 years of quality control management experience in the FDA-regulated industry, IVD experience preferred
  • 5+ years of demonstrated quality control experience
  • Strong working knowledge of ICH, cGMP, FDA and ISO guidance
  • Recent experience with method development, qualification/validation and transfer preferred
  • 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
  • Excellent computer, documentation, communication and organizational skills required
  • Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment
  • Exercises judgment within well-defined and established procedures and practices to determine appropriate action
  • Strong interpersonal and verbal/written communication skills required
  • Able to respond quickly to shifting priorities and to meet deadlines



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.