Quality Assurance Associate Ii - Document Control

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!

Position Summary:

The QA Associate II is responsible for performing day-to-day activities related to Quality Document Control (QDC) and GMP Records filing systems for both physical and electronic records. QDC will own and manage the GMP Quality business processes supporting Quality Document Control authoring, review, approval, and archive of GMP lifecycle documents.

The QDC responsibilities include following the corporate requirements for the Document Control program, making decisions within the scope of the program, while providing strong customer service and user support by answering questions and providing guidance.

Principal Responsibilities:

• Participates in continual improvement activities within Document Control and GMP Records management
• Contribute to milestones related to specific projects
• Works with off-site storage facilities to ensure compliant submission and retrieval of GMP records
• Scans and digitizes GMP records and verifies as true copies
• Execute on defined and established procedures, work instructions and templates
• Collects and assists with reporting on relevant metrics
• Answer basic questions and send routine notifications
• Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records
• Responsible for receiving and logging GMP records, cataloging, physical or electronic filing, and retrieval as needed
• Back-up the Records Management job function as required
• Works with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in a compliant manner and are readily retrievable
• Supports GMP regulatory audits and inspections ensuring timely retrieval of both physical and electronic records
• Performed reconciliation of completed records issued for GMP activities
• Process documents in electronic Document Management System
• Issue and reconcile batch records, forms, and logbooks
• Maintain and distribute documents to Controlled Document Locations
• Shift oversight at manufacturing site may require off hours and holiday support

Expected Qualifications:

• Working knowledge of cGMP, including familiarity with ICH guidance, regulatory guidance, and pharmaceutical organization guidance
• Highly organized and detail oriented
• Advanced expertise with Office 365, especially Excel
• Basic knowledge of continuous improvement principles and practices
• Excellent written and oral communication skills
• Knowledge of physical and electronic Document Management workflows and principles
• Proven ability to work effectively in a fast-paced team environment
• Experience with applicable software (e.g., Learning Management System, electronic Quality Management System, data analytics, etc.)
• Demonstrated problem-solving skills and techniques commensurate with job level
• Ability to manage day-to-day workload with minimal oversight
• Strong team player that can also work independently to achieve objectives
• Bachelor's degree in relevant field or equivalent experience; or 2+ years of relevant quality assurance, manufacturing, or quality control experience in the biotech or pharmaceutical industry

Preferred Qualifications:

• Working knowledge of current industry practices and standards
• Familiarity with cGMP and/or biotechnology industry
• Prior QDC experience

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 $71,000 to $92,000 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.
#LI-JW1