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Quality Assurance Specialist

 
Requisition ID:  3743
Location: 

Bothell, Washington, US

Date:  Nov 25, 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 Process Science & Validation Team. 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 Operations team. This position will partner with quality management to support the execution, maintenance, and continuous improvements of key Quality Systems in support of commercial biologics products.  The ideal candidate has experience with quality systems primarily related to change control, deviations and SOP writing and is adept at managing multiple priorities in a fast-paced, regulated environment.

 

ESSENTIAL FUNCTIONS:

  • Support Quality Assurance point of contacts for Lundbeck's Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs)

  • Support the review and approval of internal and external investigations, CAPAs, deviations, change controls and vendor communications

  • Support internal lot disposition activities

  • Assist with the Annual Product Quality Review Process

  • Collaborate with internal cross-functional teams including Manufacturing, Quality Control, Validation and Regulatory

  • Support and contribute to continuous improvements of the core quality systems

  • Comply with all company policies, procedures, work instructions and training requirements

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited bachelor's degree with a minimum of 4+ years of relevant experience

  • Experience with quality systems and adept at managing multiple priorities in a fast-paced, regulated environment

  • Ability to communicate effectively with internal personnel and external organizations

  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices

  • 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 SAP, Microsoft Office Suite and Adobe Acrobat

  • Team player with the ability to work collaboratively with other functions to execute Quality System requirements

  • 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 Sciences / Life Sciences

  • Experience with biologics manufacturing

  • Experience working with CMOs and/or CTLs

 

TRAVEL

  • NA

#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.


 

About Lundbeck

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best.

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases 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 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn