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Quality Assurance Specialist

 
Requisition ID:  2437
Location: 

Bothell, Washington, US

Date:  Jan 2, 2022
 

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Late-Stage Development and Production groups. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!
 

SUMMARY:

 

Lundbeck Seattle BioPharmaceuticals is seeking an experienced and highly motivated individual to join our Quality Assurance team.  This position will partner with quality management to support continuous improvements of key Quality Systems in support commercial biologics products.  The ideal candidate has experience with quality systems primarily related to change controls, SOP writing, and is adept at managing multiple priorities in a fast-paced, regulated environment. This position requires an experienced candidate able to communicate effectively with internal personnel and multiple Contract Manufacturing Organizations (CMOs) and Contract Test Laboratories (CTLs).  

 

ESSENTIAL FUNCTIONS:

  • Manage the Internal and Vendor Change Control programs and track the status and timely closure of change controls
  • Perform training on the Change Control and related Quality Systems
  • Serve as a back-up to CAPA, Deviation, and Vendor communication system administrators
  • Track, trend, and prepare applicable quality metrics for Quality Management Review meetings
  • Collaborate with multiple vendor and internal cross-functional groups including: Manufacturing, Quality Control, Regulatory, and Process Development
  • Write SOPs and assist with Quality systems development, maintenance, and improvement

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited BS/BA degree and 4+ years’ relevant experience, or a combination of education and experience totaling 9 years
  • Experience with quality systems, SOP writing, and is adept at managing multiple priorities in a fast-paced, regulated environment
  • Ability to communicate effectively with internal personnel and multiple Contract Manufacturing Organizations and Contract Test Laboratories
  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications
  • Strong understanding of Quality Systems and experienced in change control management
  • The successful candidate will have excellent written and oral communication skills, a flexible attitude with respect to work assignments, and the ability to proactively handle multiple tasks simultaneously
  • Strong computer skills, particularly with Microsoft Office Suite and Adobe Acrobat
  • Team player with the ability to work collaboratively with other functions to execute Quality System requirements and complete compliance assessments
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited bachelor's degree in Life Sciences
  • Experience with biologics
  • Experience working with CMO's and/or CTL's
  • Experience with SAP

 

TRAVEL  

  • N/A

#LI-LM1

#LI-Hybrid

 

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

 

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
 

 

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.


 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

Billions of people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.  

We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion). 

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.