Quality Control Associate

Employer
Lundbeck
Location
Bothell, WA, United States
Posted
Nov 07, 2020
Ref
1389
Discipline
Quality, Quality Control
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with sites worldwide including in Bothell, Washington, Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized 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. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

In October 2019, Lundbeck acquired Alder Biopharmaceuticals, now known as Lundbeck Seattle BioPharmaceuticals (Lu-SBP). The Lu-SBP site is responsible for antibody development and biologics manufacturing in collaboration with the global Lundbeck CMC Biologics organization.

SUMMARY

Lundbeck is seeking a Quality Control Associate to support QC testing activities for projects in both the early and late stage of clinical and commercial development. The ideal candidate is detail oriented, organized and will have some experience in a Quality Control or other scientific laboratory or setting.

ESSENTIAL FUNCTIONS
  • QC Sample Shipping and Sample Management
  • Coordinate and track sample shipments between various departments at Lundbeck and multiple CMOs/contract testing labs including international shipments
  • Lead a weekly multi-departmental sample shipping working group meeting
  • Proactively communicate shipping timelines from contract testing labs to other QC personnel and other Lundbeck contacts, as required
  • Create and review QC shipping related paperwork with accuracy including externally required sample submission paperwork for all outsourced testing.
  • Maintain accurate inventory of all samples in the Lundbeck QC sample library and at external GMP storage sites
  • Perform labeling and aliquoting of QC samples to support internal and external testing needs
  • Document all GMP work as described in Lundbeck SOPs and cGMP requirements.
  • Data Coordination
  • Perform data entry to support evaluation and trending of assay performance data and product testing data.
  • Perform data triage upon arrival to QC
  • Perform data verification for QC data
  • Support other QC personnel with data organization and archiving.


REQUIRED EDUCATION, EXPERIENCE and SKILLS:
  • Accredited BS or BA Degree and 0-2 years of related experience in biotechnology / pharmaceutical Quality Control, OR a combination of education and biotechnology / pharmaceutical Quality Control experience totaling 4-6 years.
  • Excellent written and oral communication skills and be comfortable taking direction from multiple QC personnel
  • Must have a strong ability to organize and track, as well as good attention to detail
  • Flexible attitude with respect to work assignments and enjoy working in a rapidly changing, team-based environment
  • Ability to interact with and support other various departmental personnel in execution of the above activities


PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
  • Accredited BS or BA Degree in life science or related field
  • Experience with Good Documentation Practices (GDP)


TRAVEL
  • No travel is required for this role.


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.

.buttontextcc992ff0ed1a3b04 a{ border: 1px solid transparent; } .buttontextcc992ff0ed1a3b04 a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; }

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.