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Quality Assurance Area Specialist II - API

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

 

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

 

Position Purpose

Main duties include review of batch reports for release of API materials, minor deviations, minor change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

 

Accountabilities

  • Perform activities related to Batch review
  • Review API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
  • Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
  • Review & approve minor change control requests & low complex major change controls
  • Review & approve minor deviations & low complexity major deviations
  • Provide guidance to departments regarding quality & related activities
  • Participate & provide input to root-cause analysis
  • Participate in process confirmations & quality oversight
  • Authorized person according to Novo Nordisk Quality Manual
  • Other accountabilities, as assigned

 

Required Qualifications

  • BA/BS degree in Life Sciences, Engineering, or related field or equivalent combination of education & work experience
  • Understanding of cGMP manufacturing & production processes & how to apply
  • Strong written & verbal communication skills
  • Strong computer skills in MS Office, PowerPoint, Word, Excel, etc.
  • Understanding of cGMPs in pharmaceutical manufacturing
  • Understanding of Quality & Production processes
  • Good stakeholder relations
  • Capable of prioritizing & managing workload

 

Desired Qualifications

  • Minimum of three (3) years of QA or related experience in the pharmaceutical or medical device industry
  • Understanding of the Batch review Processes
  • Understanding of quality management systems
  • Understanding of quality oversight & on floor production support

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility
  • Routinely operates & inspects manufacturing equipment using hands
  • Ability to be on feet for up to a 12-hour shift
  • Constantly positions oneself to transfer materials within manufacturing environment
  • Frequently moves about building(s) to access other personnel & operational areas
  • Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
  • Occasionally ascends/descends a ladder to access service equipment. Works atop elevated positions at heights
  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle
  • Occasionally works around odorous and/or hazardous materials
  • Occasionally performs critical job functions in extremely cold work environments
  • Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment
  • Ability to work in loud noise environments with hearing protection
  • Ability to move throughout the facility to perform duties in close proximity to process equipment & areas
  • Ability to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Ability to work in an open office environment with the possibility of frequent distraction

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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 Assurance Area Specialist II - API

Clayton, NC
Full Time

Published on 07/23/2022

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