Quality Control Specialist Equipment Management (CSV)

Quality Control Specialist Equipment Management (CSV)

Technical Operations & Process Sciences - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

This position will be responsible for overseeing the lifecycle management of all Quality Control (QC) instrumentation and related software systems. This role will be the liaison between the QC, Facilities, IT, and Quality departments to support QC equipment and associated software implementation and maintenance. This position supports equipment management operations to ensure instruments are validated, and available for use for QC sample testing in accordance with standard operating procedures (SOPs) in a cGMP compliant QC laboratory.

• Ensure Quality Control software and instruments are managed in accordance with governing procedures and regulations
• Perform periodic reviews, data integrity and impact assessments of systems
• Manage user access to instrument software
• Author and own complex change controls, deviations and CAPAs
• Create and revise standard operating procedures (SOP’s) and other documents as needed
• Support instrument and software validation by working with team in writing, executing, and approval validation documents
• Coordinate instrument-related activity with IT, Facilities, Quality, and QC lab
• Represent QC in cross-functional project teams
• Participate in regulating agency inspections, internal audits, and partner audits. May participate as subject matter expert (SME)
• Identify and lead continuous improvement projects
• Train and mentor junior staff
• A few hours of evening, weekend, and/or on-call work may be occasionally required

Required Qualifications:

• Bachelor’s degree with 6+ years or associates degree and 8+ years in a relevant field
• 4+ years relevant computer system validation experience in a GxP environment
• Strong working knowledge of computer system validation following industry standards (GAMP) and GMP regulations
• Experience authoring and owning change controls, validation documentation, deviations, and standard operating procedures
• Be highly organized with an attention to detail
• Ability to keep order over multiple projects/tasks
• Good customer service and collaboration skills
• Strong technical writing and communication skills

Preferred Qualifications:

• BS/BA degree in biological, chemical, engineering or computer science preferred
• Experience participating in regulating agency inspections, internal audits, and partner audits
• Experience with Empower, Softmax Pro, 32 Karat, Chemstation
• Experience using a Laboratory Information Management System (LIMS)
• Experience using Blue Mountain, Maximo, or other equipment maintenance management system
• Experience using Paperless Validation Software

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

The hiring pay range for this position is $83,000 to $108,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.