High-Performance Quality Assurance Specialist

2 weeks ago

Vancouver, British Columbia, Canada AbCellera Full time

At AbCellera, we are pioneering a new frontier in antibody-based medicine by breaking down conventional barriers in drug development. Our diverse team of scientists, engineers, creatives, and business professionals is driven by the conviction that advancing science can elevate lives.

We are seeking an experienced scientist to join our QC team as a High-Performance Quality Assurance Specialist. In this role, you will be instrumental in ensuring the highest standards of quality and compliance in our Quality Control testing by proficiently performing analytical method qualifications, sampling, and routine testing in accordance with approved testing methods for raw materials, in-process materials, packaging materials, and finished products.

Your daily responsibilities may include:

  • Performing sample and routine testing using approved testing methods for raw materials, in-process materials, packaging materials, and finished products while supporting environmental monitoring for cleanroom facilities
  • Contributing to method qualification/transfer activities such as writing working instructions, operational SOPs, test methods, protocols, executing, and drafting reports for method qualifications/transfers
  • Conducting all routine and stability testing in the analytical laboratory, including UPLC, CE-SDS, icIEF, SEC, and other separation and compendial techniques in accordance with FDA, USP, ICH, and internal SOPs
  • Drafting reports for out-of-specification (OOS) and/or out-of-trend (OOT) results during release and stability testing in close collaboration with internal teams and/or external testing labs
  • Maintaining strict and accurate quality control documentation of all test procedures and results in compliance with Good Manufacturing Practices (GMP)
  • Supporting the start-up and operational readiness of GMP QC labs, including facilities, calibration of equipment, methods, and procedures, and sample and data flows
  • Assisting in the execution and review of instrument qualification/requalification and Computerized System Validation

To excel in this role, you will require:

  • A bachelor's or master's degree in an applicable science, accompanied by at least 5 years of relevant QC experience
  • A strong knowledge and experience in Good Manufacturing Practices (GMPs), QC analytical and bioanalytical testing, and method qualification requirements
  • Proficiency in utilizing HPLC, UPLC, capillary electrophoresis, imaged capillary isoelectric focusing, microtiter plate reader spectrophotometer instrumentation, and software; a microbiology background is highly desirable
  • Excellent interpersonal skills, ability to work independently and in a team environment, attention to detail, and organizational skills
  • Strong analytical thinking and problem-solving abilities

In return for your expertise, AbCellera offers a competitive compensation package, which includes a base salary range of $80,000 - $100,000 CAD annually, commensurate with your education and job-related knowledge, skills, and experience. Additionally, you will receive equity, an annual bonus tied to team and company performance, a 6% RRSP contribution, a $1,500 annual Active Lifestyle Allowance, vacation time, flexible work arrangements, professional development opportunities, comprehensive health benefits, and scientific and technical mentorship.

About AbCellera

AbCellera is a global leader in discovering and developing antibody-based medicines aimed at improving patients' lives. We focus on bringing innovative therapies to patients through both internal pipeline advancements and strategic partnerships with companies possessing novel science or technology.

We value individuals who embody drive, energy, and a passion for pushing the boundaries of science and technology. Ideal candidates should share our commitment to excellence and teamwork. By joining AbCellera, you become part of a dynamic community dedicated to advancing groundbreaking therapies and fostering a culture of inclusivity and innovation.

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