Senior Specialist Quality Assurance Quality Systems
Company: NewYorkLifeScience.com
Location: Bothell
Posted on: May 14, 2022
Job Description:
Senior Specialist Quality Assurance Quality Systems 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 Sr. Specialist is a key Quality
representative for the implementation of Data integrity and Quality
Risk Management programs at the manufacturing site. The Sr.
Specialist is responsible for managing the day-to-day activities of
the data integrity and risk management programs and proactively
identifying and escalating key issues to management. The Sr.
Specialist is responsible for training staff in data integrity and
risk management principles; assisting staff with completion of
day-to-day assignments / tasks; ensuring compliance with
procedures; and implementing program improvements to align with
current industry best practices. The incumbent must be able to
interact with staff at various management levels and make
presentations to internal and external customers on specialized and
highly technical aspects of the relevant programs.
- Manage quality processes or programs, including:
- leading discussions with mid- to senior staff on status of key
activities and risks within the program
- assisting junior to mid-level staff with performing program
assessments and activities
- developing new business processes
- developing and providing training for the process or
program
- processing complex records that may involve external
parties
- developing new metrics, evaluating metrics, and reporting to
department management
- Lead the successful completion of cross-functional
projects
- Provide quality site support for the Data Integrity and Risk
Management Programs
- Ensure compliance with global directives, policies and current
industry expectations
- Write/revise and collaborate on Quality directives, and approve
standard operating procedures that impact multiple departments or
programs based on industry best practices; ensure documents reflect
current practices
- Participate as an SME in audits and inspections, as needed
- Represent Quality Systems on cross-functional teams or teams
with external parties
- Lead continuous improvement activities that may involve a
team
- Make independent decisions within the areas of expertise, with
support from management on more complex issues
- Conduct and manage cGMP Risk Assessment/Analysis using various
Risk Assessment tools
- Coordinates and continuously support the Data Integrity and
Quality risk management programs at the site
- Participates in global Data integrity and Risk Management
initiatives as a site representative
- Train, coach and facilitate risk assessment teams using various
risk assessment tools
- Promote a high commitment to Data Integrity and Risk Management
quality and compliance at the site Required Qualifications:
- 10+ years in GMP operations, preferably in the
biopharmaceutical or the pharmaceutical industry
- Working knowledge of current industry practices and
standards
- Experience with managing risk related to cGMP Manufacturing and
Testing
- Experience with managing Data Integrity in Pharmaceutical
industry using ALCOA+ principles
- Experience in regulatory inspections Advanced expertise with
Office 365, especially Excel
- Experience with applicable software (e.g., Learning Management
System, electronic Quality Management System, data analytics,
etc.)
- 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 in the biotech or pharmaceutical
industry Preferred Qualifications:
- Six-Sigma Certification 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. NewYorkLifeScience.com, owned and published by
Info.Resource, Inc. , is a resource
for the life science industry in the state of New York.
Keywords: NewYorkLifeScience.com, Seattle , Senior Specialist Quality Assurance Quality Systems, Other , Bothell, Washington
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