Quality Control Validation Area Specialist I – Clayton, NC (On-site)
Job Summary:
Novo Nordisk is seeking a Quality Control Validation Area Specialist I to support laboratory validation activities and manage QC equipment compliance at its advanced aseptic manufacturing site in Clayton, North Carolina. The ideal candidate will bring expertise in laboratory instrumentation, validation protocols, and change control, with a strong foundation in GMP standards. This is an on-site role in a fast-paced, regulated pharmaceutical environment.
Key Responsibilities:
Plan and execute laboratory validation activities for QC equipment and systems.
Review and maintain accurate validation documentation per GMP and corporate quality standards.
Manage change control processes for QC equipment and instrumentation.
Ensure timely collaboration with IT, metrology, and cross-functional stakeholders.
Identify deviations and address them following established SOPs.
Maintain equipment records in validated systems such as TIMS and SAP PM/QM.
Ensure compliance with environmental, health, and safety protocols during all activities.
Required Skills & Qualifications:
Education:
Bachelor’s Degree in Life Sciences, Chemistry, Engineering, or related field required.
Associate’s Degree may be considered with 4+ years relevant experience.
Experience:
Minimum 2 years in laboratory validation, equipment qualification, or engineering in the pharma industry.
Experience with electronic validation systems (e.g., TIMS), SAP PM/QM is a plus.
Familiarity with validation protocol writing, GMP compliance, and QC lab systems.
Technical Proficiency:
Working knowledge of lab instruments, validation lifecycle, and GMP documentation practices.
Ability to manage technical projects and support process improvement initiatives.
Perks & Benefits:
Competitive salary with annual performance bonus
14 paid holidays and generous time off policy
Medical, Dental, and Vision Insurance effective from Day 1
8% guaranteed 401(k) contribution plus employer match
14 weeks Paid Parental Leave and 6 weeks Paid Family Medical Leave
Tuition assistance and employee referral awards
Access to Novo Nordisk-marketed pharmaceutical products
Company Description:
Novo Nordisk is a global leader in diabetes and chronic disease care, with over a century of innovation. The Clayton, NC facility is a cutting-edge aseptic "fill and finish" site supporting injectable diabetes and obesity treatments. The site operates under strict cGMP compliance and fosters collaboration among world-class manufacturing professionals.
Work Mode: On-site
Location: Clayton, North Carolina, United States
Salary Range: Not specified (competitive with performance bonus)
Call to Action:
Ready to drive quality excellence in a world-class pharmaceutical environment? Apply now to join Novo Nordisk’s mission to change lives with breakthrough therapies.
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