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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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Process Area Specialist, QC Support & IQC Job

Date: Dec 15, 2018

Location: Clayton, NC, US

Company: Novo Nordisk

Position Purpose:
Serves as area specialist for the QC Support & IQC areas. Responsible for ensuring the timely completion of quality items (e.g., CAPAs, deviations, change requests, QAPs), process confirmations, assisting in resolution of vendor quality-related challenges, method transfers, validation, & other duties as assigned in compliance with applicable regulations & company policies/procedures. Works in accordance with the Novo Nordisk Way. Leads initiatives to drive process improvements within the IQC/QC Support areas. Process group responsible for PPM/OPC.

Accountabilities:
  • Timely completion of quality items (deviations, CRs, QAPs, etc.)
  • Process confirmations & follow-up actions related to these
  • Resolution of vendor quality-related challenges
  • Method transfers
  • Collaboration & process improvement with stakeholders & team members.
  • Working in accordance with the Novo Nordisk Way
  • Demonstrating a Quality & cLEAN Mindset.
  • Perform other duties, as assigned.


Required Education: BA/BS in Chemistry, Microbiology or BA/BS degree with a relevant combination of experience.

Required Experience: Minimum of five (5) years of laboratory experience in the pharmaceutical industry or related field. Experience in method transfer, deviation investigations, change requests, validation & systematic problem solving.

Technical/Process/Functional Knowledge:
  • Working knowledge of GMPs & compendial requirements (USP/EP/JP).
  • Demonstrated ability to write technical & scientific documents & reports.
  • Demonstrated ability to present technical & scientific information to others.
  • Ability to work with customers & suppliers in a cooperative manner.

Organization/Planning: Demonstrated ability to manage multiple projects & competing priorities

Physical & Other 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.
  • Occasionally ascends/descends a ladder to take samples.
  • Occasionally works around odorous and/or hazardous materials.
  • Able to travel internationally, up to 5% of the time.
  • 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.


Requisition ID: 59150BR
State/Provinces: Clayton
Job Category: Quality


Nearest Major Market: Raleigh

Job Segment: Microbiology, Pharmaceutical, Laboratory, Business Process, Science, Management