Quality Assurance Associate III External Quality

Seattle Genetics Bothell , WA 98021

Posted 2 months ago

Summary:

The Seagen Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients. The QA Associate III position is responsible for reviewing batch production records and associated documentation to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations.

Responsibilities:

  • Manage lot review activities for late phase and commercial GMP Intermediates, APIs, and Drug Products to ensure disposition timelines are met

  • Review and manage deviations from contractors related to manufacturing and testing

  • Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP expectations

  • Communicate and resolve discrepancies with CMOs

  • Compile and manage lot files

  • Enter data in to process monitoring system draft PQR sections

  • Participate in quality system improvements

  • Revise standard operating procedures and associated work instructions. Authoring SOPs is also possible under supervision

  • Monitoring local and global team meetings and project progress to ensure efficient and effective communication on project status and issues

  • Create and revise Standard Operating Procedures as needed

  • Participate in regulatory inspections

Qualifications:

  • 5+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA

  • Working knowledge of cGMP, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance

  • Experience working with the production and testing of pharmaceuticals (biologic or small molecules)

  • Very detail-oriented team player with effective planning, organization, and execution skills

  • Excellent communication skills with internal and external personnel essential

  • Experience with electronic documentation management systems (EDMS)

  • Strong computer skills with Word and Excel

  • Ability to work effectively at a fast pace with cross functional departments

  • Innovative, proactive, and resourceful; committed to quality and continuous improvement

  • Ability to anticipate and mitigate challenges

  • Experience working with clinical and commercial products and supporting regulatory inspections desired

  • Occasional travel up to 10% of time

Education:

  • BS/BA or Master's Degree in a relevant field

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 visitwww.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.

#LI-DD1

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Specialist Quality Assurance Cell Therapy

Bristol Myers Squibb

Posted 3 weeks ago

VIEW JOBS 5/23/2021 12:00:00 AM 2021-08-21T00:00 At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. The Quality Associate Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (JuMP). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports JuMP's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at JuMP with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment. The primary focus of the QA Associate Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at JuMP by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications. This is a Weds-Sat shift (PM) Education and Experience: Education: * Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required. Experience * 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. * Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus. * Hands-on experience with batch record review and product disposition is preferred. Knowledge, Skills, and Abilities * Strong computer skills with Word and Excel and other electronic manufacturing systems. * Detail oriented team player with effective planning, organization and execution skills. * Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. * Good organization and time management skills. * Ability to work in a high paced team environment. * Strong written and verbal skills. DUTIES AND RESPONSIBILITIES: Key Responsibilities * Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors. * Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations. * Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations. * Review deviations, product non-conformities, and GMP investigations to ensure adequate. * Own department events and minor deviations. * Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations. * Oversee manufacturing operations during patient material receipt and drug product pack out. * Support the review and approval of incoming raw materials, routine preventive and calibration of equipment. * Support internal and external audits, including documenting observations and implementation of corresponding CAPAs. * Lead small scope projects as assigned. * Revise Standard operating Procedures as needed. * Train and mentor junior team members. BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Bristol Myers Squibb Bothell WA

Quality Assurance Associate III External Quality

Seattle Genetics