Sr. QA Specialist - Pharmaceutical Manufacturing

Role Summary

Onsite role in West Lebanon, NH, at a 24/7 GMP biologics manufacturing facility. Supports management in setting future quality direction and implementing goals by applying best practices from other Novo Nordisk sites. Performs reviews and approvals of manufacturing and support documentation to certify compliance with specifications and GMP; holds QA signature authority on batch records and related records. Develops and coaches QA colleagues, supports manufacturing on the floor, and leads quality improvement initiatives and cross-functional projects.

Responsibilities

• Training, mentoring and developing other QA colleagues
• Identifying and assessing training needs and delivering training materials and programs, including training on compliance-related issues and other QA topics
• Serve as GMP expert 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, and deviation issues
• Informing 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

Qualifications

• Education and Certifications:
  • Required: Bachelor's Degree within a scientific or life science
  • Preferred: Master's Degree
• Work Experience:
  • Required: Bachelor's Degree with ten (10) years experience
  • Preferred: Master's Degree with eight (8) years experience
  • Preferred: Six (6) years of direct QA experience
• Knowledge, Skills, and Abilities:
  • 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
  • Normally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutions
  • 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

Additional Requirements

• Local and International Travel: 0-5%
• Physical requirements: Primarily sedentary; may require walking/standing occasionally; ability to lift up to 10 pounds; close activities such as reading and writing