Quality Assurance Specialist

Employer
Lundbeck
Location
Bothell, WA, United States
Posted
Dec 17, 2020
Ref
1540
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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.

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders.

SUMMARY:
Primary responsibilities include managing deviation and Corrective and Preventive Action (CAPA) programs, serve as back-up change control administrator, prepare quality metrics, and write/revise Quality System SOPs.

ESSENTIAL FUNCTIONS:
  • Manage the deviation and Corrective and Preventive Action (CAPA) programs and track the timely closure of internal and CMO deviations and CAPA's
  • Serve as a back-up change control administrator for internal and CMO change controls, and assist in closure as needed
  • Track, trend, and prepare quality metrics
  • Participate in Subject Matter Expert (SME) based teams to resolve technical Quality related issues
  • Partner with quality management to support continuous improvements of key Quality Systems (Deviations, CAPA, Change Control) in support of commercial products.
  • Collaborate with multiple CMOs and cross functional groups including: Biologics Production, Quality Control, Regulatory, Supply Chain and Process Development
  • Write SOP's and assist with Quality systems development, maintenance, and improvement


REQUIRED EDUCATION, EXPERIENCE and SKILLS:
  • Accredited BS/BA degree and 5 years' experience in the pharmaceutical, biotech or medical device industry, or a combination of education and experience totaling 9 years in the pharmaceutical, biotech or medical device industry
  • Experience with quality systems and writing SOP's
  • Adept at managing multiple priorities in a fast-paced, regulated environment
  • Ability to communicate effectively throughout all levels of an organization
  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines
  • Strong understanding of Quality Systems and experienced in deviation and change control management
  • 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 executes Quality System requirements and complete


PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
  • Accredited bachelor's degree in Life Sciences
  • Commercial experience working in a quality organization
  • Experience working with CMO's
  • Compliance assessments
  • Understanding of industry best practices for biologics and parenteral applications


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.

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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.

Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

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