Seagen
Quality Assurance Associate II
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:
An Associate II in Records & Archive Management is responsible for supporting the management and maintenance of GMP Records filing systems for both physical and electronic records retention systems. The position involves the digitization process of physical records to electronic records. The responsibilities include providing customer service and user support; collaborating on controlled documents within area of responsibility; participating on functional teams; contributing to project milestones and continuous improvement activities; supporting audit and inspection requests; and interfacing with business process owners from other GxP programs.
Principal Responsibilities:
- Perform day-to-day activities within the GMP Records & Archive Management program, including:
- Executing defined and established procedures
- Maintaining GMP records in the GMP Archive
- Providing basic training
- Supporting customers and answering questions
- Digitizing GMP records and verifying true copies
- Reconciling issued records
- Maintaining offsite record storage
- Collecting data for metrics
- Providing support for validation activities
- Contribute to milestones associated with specific projects
- Revise or collaborate on program procedures
- Provide support for audits and inspections, as needed
- Participate in functional teams within quality processes or programs
- Participate in continual improvement activities
- Other duties as assigned
Required Qualifications:
- Advanced expertise with Office 365, especially Excel
- Knowledge of physical and electronic Document Management workflows and principles
- Knowledge of good documentation practices and good records management practices
- Basic knowledge of continuous improvement principles and practices
- Excellent written and oral communication skills
- Demonstrated problem-solving skills and techniques commensurate with job level
- Ability to manage routine and non-routine workload with little-to-no routine oversight
- Bachelor's degree in relevant field; or associate degree +2 years of relevant experience records management
Preferred Qualification:
- 2+ years in GMP operations, preferably in the biopharmaceutical or
- Working knowledge of cGMP, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance.
- Experience with applicable software (e.g., electronic Document Management System).
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, 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: 06/10/2022
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