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Quality Control Scientist - Microbiology

About the Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

 

 

Key Responsibilities

The Quality Control (QC) Scientist - Microbiology is responsible for microbiology method optimization, data review, engagement with regulatory authorities, and technical mentorship. The QC Scientist – Microbiology adopts and maintains a culture of excellence and quality in all aspects of his/her job function. This position works in a highly regulated environment and aids in ensuring that the Quality Management System methods and Quality System Regulations are applied throughout Novo Nordisk.

 

The individual in this role will have a deep understanding of the Quality Control environment/testing techniques, Current Good Manufacturing Practices (cGMP’s) and quality systems with the ability to look across the department.

 

 

Main Job Tasks

  • Lead local QC projects with the ability to plan, execute and work both within the department as well as cross functionally
  • Write and review procedures to ensure alignment with corporate procedures
  • Design and lead team in executing experiments as needed, including summarizing results in technical reports. Perform data review as needed
  • Provide mentorship and guidance to QC Microbiologists on routine tasks and assigned projects
  • Champions innovation and improvements in laboratory flow, simplification of daily tasks and improve robustness of assays
  • Enhance robustness with respect to ensuring release of product on time
  • Investigates and conduct root cause analysis for deviations related to QC with no assistance
  • Represent site at health authority inspections. Author responses to regulatory agencies
  • Updates and maintains trending files and provides routine summaries of trending to support investigations
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
  • Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

 

Knowledge, Skills & Abilities and Experience

Education

  • MS with five (5) plus years in GMP environment
  • or PhD with two (2) plus years’ experience in GMP environment

 

Experience

A minimum two (2) years’ experience in a project lead role is preferred.

 

Skills & Abilities

  • Must be able to work independently in a team-based setting and function in a rapidly changing environment while balancing multiple priorities simultaneously
  • Able to conduct system and data review
  • Experience in Quality Control is required
  • Experience with Health Authority inspections is a plus
  • Excellent analytical and writing skills are also required with the ability to author/review scientific and technical reports

 

Physical Requirements

  • The ability to push, pull, lift, finger, feel, and grasp
  • The ability to speak, listen, and understand verbal and written communication
  • Repetition including substantial movement of wrists, hands, and or fingers
  • Lifting up to 33lbs/15kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
  • The worker is required to function in narrow aisles or passageways
  • Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations
  • The working environment includes a variety of physical conditions including: noise, inside and outside conditions including temperature changes; proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals
  • Local and International travel: 0-5%

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Quality Control Scientist - Microbiology

Lebanon, NH
Full Time

Published on 07/29/2020