Apply Now

Quality Associate

Arvada, CO, USA Req #418
Monday, August 5, 2019

Our products enable the biopharmaceutical industry to be at the forefront in the development and advancement of treatments for serious diseases. Earning sales revenue of more than 1.4 billion in 2017 our people come from over 60 nations at 50 sites in 33 countries.

What you can look forward to accomplishing:

  • Ensure compliance with all applicable regulations including but not limited to 21 CFR Part 820,  and ISO 9001, Quality Management Systems, as it pertains to import/distribution of regulated and nonregulated products as well as the manufacturing processes of non-regulated product/Research Use Only (RUO) products.

  • Ensure compliance with site procedures and global policies.

  • Perform all duties as required to maintain a robust QMS including: Internal Audits, Management.  Reviews, CAPA, Deviations, Incident/Events, Document Control, and Engineering Change Control.

  • Oversee and monitor the quality of manufactured/assembled Product in Arvada.

  • Assist in investigation and the disposition of nonconforming product and returns.

  • Educate and instruct the site personnel in the recommended quality topics and procedures.

  • Host and support all Third Party Audits and Customer Audits concerning the site’s Warehousing activities and BPS manufacturing.

  • Work on projects as directed by Quality Systems Manager.

  • Assist with the local Arvada management team (C-TPAT, E&HS), as needed.

  • Assist the team with continuous improvements and establishing and monitoring Key Performance Indicators (KPIs).

  • Support the Virus Analytics QA/QC associate, establish a cross training program that will allow both positions to cover each other.

  • Other duties as assigned.

     

    Skills and experience that you need to bring to the company:

 

Education:

  • BS degree with minimum 5 years of related work experience. Science, technical or engineering discipline preferred.

Experience:

  • Understanding of basic quality processes (i.e. Internal Auditing, CAPA, deviations, complaint handling, inspections, etc.).  

  • Knowledge of documented Quality Management Systems and Regulations.

  • Experience in maintaining quality system requirements according to ISO 9001 or cGMP.

  • Knowledge of Good Manufacturing and Distribution Practices (cGMP).

  • Auditing Experience is required.

  • Experience with procedure and report writings.

  • Experience and knowledge of good documentation practices.

  • Knowledge of Lean Six Sigma preferred.

License/Certification:

  • ASQ Certification in Quality preferred.

Other Skills (ex. specific computer skills, level of oral/written communication, etc.):

  • Team-Oriented

  • Decision making and problem solving.

  • Communication Proficiency

  • Collaboration Skills

  • Proficient in Microsoft Computer Application, such as Word, Excel, PowerPoint, Visio, etc.

  • Working knowledge of SharePoint.

  • Working knowledge of SAP, ERP system(s).

  • Strong Technical writing Skills

  • Experience in customer service and interactions

  • Ability to work independently and a team environment

  • Must be willing and able to travel 10% of the time

  • Strong identification with our core values: Sustainability, Openness, Enjoyment

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.


All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin.  We are also an equal opportunity employer of individuals with disabilities and protected veterans. 

Please view equal employment opportunity posters provided by OFCCP here
 

https://e-verify.uscis.gov/esp/media/resourcesContents/EverifyPosterEnglish.pdf
 

https://e-verify.uscis.gov/esp/media/resourcesContents/EverifyPosterSpanish.pdf
 

https://e-verify.uscis.gov/esp/media/resourcesContents/WebBPPOSTERRtoWEnglishversion.pdf
 

https://e-verify.uscis.gov/esp/media/resourcesContents/WebBPPOSTERRtoWSpanishversion.pdf

  • Arvada, CO, USA