Seagen
Quality Control Analyst III
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!
Position Summary:
Performs routine and non-routine microbiological testing with advanced proficiency and general QC laboratory work including environmental and facility clean utility monitoring, testing in-process and/or release of Seagen’s clinical development and/or commercial products in a GMP testing environment. Performs report technical writing, data analysis and various evaluations in support of site environmental and clean utility monitoring programs. Must be able to work weekends, off-shifts, and overtime as required. Applicant must be willing and able to work reliably on a flexible schedule, Monday – Friday and some weekends, to meet the demands of the project.
Principal Responsibilities:
- Applying the principles of good manufacturing practices (GMP) on a daily basis
- Creating, verifying and reviewing, as appropriate, monthly and quarterly environmental and clean utility monitoring trend reports
- Creating, verifying and reviewing, as appropriate, objectionable organism evaluations
- Performing routine and non-routine sample testing
- Reviewing assays/data for compliance to applicable operating procedures, test methods, and/or specifications/ limits
- Creating and revising standard operating procedures (SOP’s) and other documents as needed for change or improvement
- Identifying and leading continuous improvement projects
- Participating in the qualification and validation of test methods
- Troubleshooting laboratory or system anomalies
- Authoring and owning deviations, CAPAs and Change Controls
- Method or system development and/or optimization
- Training other personnel
- Serving as SME for environmental and clean utility monitoring programs or other areas of expertise
Expected Qualifications:
- Bachelor's degree in a relevant field (in addition to 5+ years of relevant experience)
- Strong subject matter expertise with respect to environmental and clean utility monitoring programs
- Strong technical expertise with respect to microbial organism identification and objectional organism evaluations
- Strong technical writing and communication skills
- Experience authoring or revising Standard Operating Procedures, Change Controls, deviations and CAPAs
- Be highly organized with an attention to detail
- Strong data interpretation/analytical skills
- Strong troubleshooting skills
- Strong knowledge of GMP compliance
- Participation in Laboratory Investigations
- Broad experience with Microsoft Office products
Preferred Qualifications:
- 5+ years of microbiology laboratory experience and/or cGMP laboratory 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 $83,000 - $108,000 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 09/08/2023
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