Seagen

Quality Assurance Specialist

Technical Operations & Process Sciences - Bothell, Washington

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

The Quality Assurance Specialist is responsible for Quality oversight of facilities, utilities, and warehousing operations at the North Creek manufacturing facility. In conjunction with the area management, the position is responsible for ensuring that activities remain in compliance with FDA and ICH guidelines, global regulatory expectations and international cGMPs. The Specialist will serve as a quality point of contact and quality subject matter expert for Real Estate and Facilities, Manufacturing, and Materials Management to ensure cGMP compliant operations at the site.

Works under consultative direction toward predetermined goals and objectives and contributes to those goals and objectives. Assignments are largely established in accordance with schedules and deliverables and are often self-initiated

Responsibilities:

• Review/Approve Deviations, CAPAs, and Change Controls related to facility, utilities, automation, and warehouse (WHSE). Monitor open quality system records to closure.
• Review/Approve Facilities, Utilities, Automation, Warehouse records to ensure compliance with approved directives/specification, site procedures and cGMP expectations.
• Review/Approve quality system documents such as SOPs, Work Orders, others as needed.
• Provide Quality oversight of facility related programs including calibration and maintenance, facility/utility monitoring, pest control.
• Provide select Quality oversight of WHSE activities (shipping, receiving, materials storage and issuance).
• Provide MQA (Manufacturing Quality Assurance) support as needed (area walk-throughs, other as assigned).
• Provide close cross communication and collaboration with Customers and site MQA on site activities (e.g., warehouse activities, pest control and facility maintenance shutdown).
• Assist with reporting and/or presentation of department metrics.
• Participate in audits: internal, external (vendor, partner), and regulatory inspections.
• Other duties as requested

Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent with 10 years or more relevant industry experience in a cGMP regulated environment such as Quality Assurance, Facilities, Manufacturing.
• Knowledge of cGMP and applicable FDA/international regulations.
• Experience with clinical and commercial operations, pharmaceutical/biotechnology manufacturing, maintenance/calibration, and automation systems knowledge a plus.
• Detail oriented team player with effective planning, organization, and execution skills.
• Excellent communication skills with internal and external personnel essential
• Ability to work effectively at a fast pace with cross site/functional departments
• Innovative, proactive, and resourceful: committed to continuous improvement
• Experience with quality management systems (QMS), electronic documentation management systems (EDMS), ERP and maintenance systems (i.e., MAXIMO or other)
• Experience supporting audits and regulatory inspections
• Ability to lift up to 25 Pounds

Preferred Qualifications:

• Knowledge and experience with US/EU GMPs, ICH and other applicable international regulations.
• Experience with the production facilities, utilities, and automation of pharmaceutical industry (biologic).
• Experience working with calibration and maintenance preferred.
• Excellent communication skills and proven ability to work well with internal and external teams.
• Experience with electronic documentation management systems preferred.
• Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality.

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.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/27/2022