Seagen

Quality Assurance Specialist/Senior Specialist, Validation

Technical Operations & Process Sciences - Bothell, Washington

Description

Summary

The Site Quality Validation Specialist collaborates with Facilities, Engineering, MSAT, Manufacturing, and other Quality experts to ensure the quality of products and compliance with internal standards, international regulatory expectations, and industry best practices. The Site Quality Validation Specialist provides quality oversight of facility/utility, equipment, method, and process validation documents to support clinical and commercial manufacturing. In addition, the Site Quality Validation Specialist provides quality expertise for the standards and requirements for facilities, utilities, equipment, computer systems, cleaning, and processes. The incumbent is responsible for reviewing, editing and approving deviations, corrective actions, change controls, SOPs, reports, and other documentation. This role participates in quality decisions related to elements of the qualification/validation lifecycle executed in support of site operations.

Principal Responsibilities:

• Support or serve as site Quality for one or more validation area:
• Primarily process validation (and review of process monitoring data for CPV), test method validation (and periodic review of validated test methods), cleaning validation.
• May also support shipping validation, equipment, utility, CSV.
• Develop, revise, and/or review SOPs associated with validation, as required Review/collaborate and/or approve SOPs, validation plans, protocols, and/or reports, as required.
• Develop validation master plans (VMPs), and VMP summary reports.
• Review and approve product validation plans, protocols, and reports.
• Provide quality validation support for internal GMP audits, as required.
• Participate in GMP regulatory and QP inspections, as required.
• May provide expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance.
• Perform change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state.
• Support review and approval of deviations/incident handling to assess impact on validation, as needed.
• Provide data integrity support to site and partner with corporate data integrity group.
• Review CMC sections of NDA/BLA and perform quality review of CMC sections, as needed

Required Qualifications:

• BS/BA with 8+ (Specialist) 10+ (Sr. Specialist) years relevant GMP and validation experience
• Strong working knowledge of validation (process/system) following industry standards (GAMP, ISPE, ICH), and cGMP is required, including ability to interpret and apply industry specific guidance's
• Working knowledge of process validation, process characterization, technology transfer and continued process verification
• Previous experience working with change management systems
• Excellent written and verbal communication skills
• Ability to proactively identify and implement continuous improvements
• Proven ability to work effectively in a fast-paced team environment
• Ability to organize information in a consistent and readily retrievable manner

Preferred Qualifications:

• Prior QA facility experience
• Previous audit experience
• Data Integrity experience
• Involvement with industry groups such as PDA and/or ISPE

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: 05/20/2022