Skip to main content

Quality Control Analyst III- Microbiology

About the Department

At Novo Nordisk, we want to make a difference. For more than 95 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Help us bring quality to life. Our filling and finishing facility (DFP) is a 457,000 square foot aseptic "fill and finish" manufacturing facility located in Clayton, NC and employs more than 850 people. The facility is part of a global network of manufacturing sites responsible for several key steps in the diabetes treatment manufacturing process, including sterile formulation, filling, inspection, device assembly and packaging. Producing medicines is a special responsibility. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day. Are you ready to make a difference?

 

 

Position Purpose

Perform & review analysis of in-process, release & stability samples of API and/or filled product in accordance with Current Good manufacturing Practice (cGMP), site & corporate policies & procedures. Transfer of technology & processes in accordance with relevant project plans & timelines. Provide leadership for other analysts as they execute their daily tasks.

 

 

Accountabilities

  • Accuracy & Scientific Soundness of Lab Data
  • Environmental Compliance
  • GMP Compliance of Laboratory
  • Maintain testing proficiency for methods
  • Timeliness of Lab Results & Investigations
  • Analysis of Samples
  • Author Deviations
  • Coach other analysts
  • Data Trending & Tracking
  • Develop process competence across DFP/DAPI
  • Drive or participate in event response activities on own site
  • Drive process improvement in Site Clayton QC 
  • Ensure all Analyst testing of samples is complete
  • Ensure departmental documents are current & standardized
  • Laboratory Equipment Validation & System support
  • Laboratory IT System support
  • Leverage solutions to other sites in DFP/DAPI
  • Perform deviation & change control activities
  • Support other DFP/DAPI sites when relevant
  • Support Deviations
  • Systematic Problem Solving
  • Other accountabilities, as assigned

 

Required Education

BA/BS degree in a scientific field or equivalent combination of education & relevant experience.

 

Experience

Minimum of seven (7) years of experience in a clinical or industrial/pharmaceutical laboratory.

 

Technical/Process/Functional Knowledge

  • Ability to author scientific & technical reports
  • Able to perform routine testing per Standard Operating Procedures (SOP) & GMP standards
  • Change control, deviation, trending
  • Knowledgeable in GMP & laboratory techniques
  • Must demonstrate attention to detail
  • Project Management experience
  • Serve as a subject matter expert on QC processes
  • Strong communication skills (verbal & written)
  • Troubleshooting for laboratory equipment
  • Validation & technical transfer experience
  • Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis)

 

Organization/Planning

Ability to execute testing according to a structured plan.

 

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds, using various body positions
  • Ability to perform close precision work with hands
  • Ability to remain in a stationary position up to 50% of the time
  • Corrected vision to 20/30 & ability to see all colors
  • Occasionally ascends/descends a ladder to take samples
  • Occasionally works around odorous and/or hazardous materials
  • Ability to attain clean room gowning certification
  • Ability to work with hazardous materials & chemicals, including sanitants
  • Ability to work near operating equipment
  • Able to move throughout the facility to interact with other employees in the normal office & manufacturing environment
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to adjust schedule to work with colleagues in other international time zones
  • Able to travel internationally, if necessary

 

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 Analyst III- Microbiology

Clayton, NC
Full Time

Published on 06/09/2020