Novo Nordisk Microbiology Job – Quality Control Scientist
Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our haemophilia 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.
Job Title: Quality Control Scientist – Microbiology
Facility: Quality
Location: West Lebanon, NH, US
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
Novo Nordisk Microbiology Job
- 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 the 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 the release of the 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 a GMP environment
or PhD with two (2) plus years’ experience in a GMP environment
Experience
Novo Nordisk Microbiology Job
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
Novo Nordisk Microbiology Job
- The ability to push, pull, lift, finger, feel, and grasp
- The ability to speak, listen and understand verbal and written communication
- Repetition including the 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 - Novo Nordisk Microbiology Job 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%
