Novo Nordisk

Senior QA Specialist – Pharmaceutical Manufacturing

Novo Nordisk

full-time

Posted on:

Location Type: Office

Location: West Lebanon • New Hampshire • United States

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Job Level

Senior

About the role

  • Responsible for training, mentoring and developing other QA colleagues
  • Responsible for identifying and assessing training needs and delivering training materials and programs
  • Serve as Good Manufacturing Practice (GMP) expert that responsible for evaluating and improving the effectiveness of training programs
  • Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues
  • Inform stakeholders regarding project goals and deliverables
  • Consult and mentor across business operations and provide specialized knowledge
  • Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting/trending
  • Reviews and approves Validation Documentation
  • Reviews and assesses Corrective and Preventive Action Reports
  • 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
  • Other duties as assigned

Requirements

  • Bachelor’s Degree within a scientific or life science required
  • Master’s Degree preferred
  • Bachelor’s Degree with ten (10) years experience required
  • Master’s Degree with eight (8) years experience preferred
  • Six (6) years of direct QA experience preferred
  • Excellent written and verbal communication and negotiating skills in English are required
  • Strong planning and organization skills, with flexibility for changes in work priorities
  • Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken
  • Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors
  • Ability to train and/or mentor Junior team members in QA Best Practices
  • Extensive knowledge in GMP API manufacturing in the pharmaceutical Industry
  • Have proven experience with GMP manufacturing in the pharmaceutical industry
  • Have good stakeholder management skills and collaboration skills at all levels of the organization.
Benefits
  • Inclusive recruitment process
  • Equality of opportunity for all job applicants
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPQA Best PracticesValidation DocumentationCorrective and Preventive Action ReportsDeviations evaluationData analysisTraining program developmentTraining materials deliveryInternal auditsRecord reviews
Soft Skills
MentoringCommunication skillsNegotiating skillsPlanning skillsOrganizational skillsJudgmentCollaboration skillsStakeholder managementFlexibilityProblem-solving