Sr. QA Specialist

Description

• Responsible for training, mentoring and developing other QA colleagues
• Responsible for identifying and assessing training needs and delivering training materials and programs, to include training of team members on compliance related issues and other QA related topics
• 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
• 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:
• Bachelor’s Degree within a scientific or life science required
• Master’s Degree preferred
• Work Experience:
• 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

• 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