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QC Analyst - OFP

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. We are currently seeking top talent for our new OFP tableting facility located in Durham, NC.

 

 

Position Purpose

Perform & review analysis of in-process, release & stability samples in accordance with current Good Manufacturing Practice (cGMP), site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines.

 

 

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
  • Supports Deviations
  • Other accountabilities, as assigned

Qualifications for Level I 

  • BA/BS in a science or related field of study
  • Minimum of one (1) year of experience in a clinical or industrial/pharmaceutical laboratory
  • Ability to author scientific & technical reports
  • Able to perform routine testing per Standard Operating Procedure (SOP) & GMP standards
  • Basic troubleshooting for laboratory equipment
  • Knowledgeable in GMP & laboratory techniques
  • Must demonstrate attention to detail
  • Strong communication skills (verbal & written)
  • Skills or knowledge in the following discipline: Chemistry Analysis of tablets including UPLC and Dissolution
  • Ability to execute testing according to a structured plan

Qualifications for Level II

  • BA/BS in a science or related field of study
  • Minimum of three (3) year of experience in a clinical or industrial/pharmaceutical laboratory
  • Ability to author scientific & technical reports
  • Able to perform routine testing per SOP & GMP standards
  • Change control, deviation, trending
  • Knowledgeable in GMP & laboratory techniques
  • Must demonstrate attention to detail
  • Serve as a subject matter expert on Quality Control (QC) processes
  • Strong communication skills (verbal & written)
  • Troubleshooting for laboratory equipment
  • Validation & technical transfer experience
  • Skills or knowledge in the following discipline: Chemistry Analysis of tablets including UPLC and Dissolution
  • Ability to execute testing according to a structured plan

Qualifications for Level III

  • BA/BS degree in a scientific field or equivalent combination of education & relevant experience. (required)
  • Minimum of seven (7) years of experience in a clinical or industrial/pharmaceutical laboratory
  • Ability to author scientific & technical reports
  • Able to perform routine testing per SOP & GMP standards
  • Change control, deviation, trending
  • Knowledgeable in GMP & laboratory techniques
  • Must demonstrate attention to detail
  • 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 the following discipline: Chemistry Analysis of tablets including UPLC and Dissolution
  • Ability to execute testing according to a structured plan

Physical Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility using various body positions
  • Able to do close precision work with their hands
  • Must be able to remain in a stationary position 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
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation

 

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.

QC Analyst - OFP

Durham, NC
Full Time

Published on 05/21/2020