Senior Specialist, Data Services (Stability)

Merck KGaA Darmstadt Germany - Wilson, NC

Full-time - Mid Level

Onsite - Wilson, NC

Chemical Manufacturing

About the position

The QC Data Services Senior Specialist is responsible for managing the NASU Stability program, including stability plan maintenance, coordination of monthly stability pulls, and support for stability-related change controls, Quality Notifications, and CAPAs. This role requires mastery of stability management and documentation programs and ensures compliance with FDA & GMP regulations while maintaining positive relations with internal and external manufacturing and packaging sites.

Responsibilities

• Manage NASU Stability program and maintain stability plans.
• Coordinate monthly stability pulls and ensure timely delivery.
• Support stability-related change controls, Quality Notifications, and CAPAs.
• Demonstrate mastery of stability management and documentation programs (GLIMS, SDS, MEDS, IPI, SAP, etc.).
• Maintain positive site relations and support third-party manufacturing and packaging sites.
• Ensure compliance with FDA & GMP regulations.
• Influence teams and act as a recognized resource for others.
• Participate in development of objectives aligned with site goals.
• Initiate and lead problem-solving efforts to prevent reoccurrence of issues.
• Approve qualification, change control, procedures, and other documents in a timely manner.
• Coordinate stability sample pulls and delivery to labs as per schedule.
• Act as a QMS topic lead for Topic 5.3 'Expiration, Retest Dating and Stability'.
• Manage quotes and POs for external laboratory testing and set up international shipments.
• Support stability chamber audits, excursions, and improvement initiatives.
• Serve as a liaison between NASU teams, Leadership, and External Entities.
• Participate in internal and external audits and inspections.
• Create and revise Standard Operating Procedures, Forms, and other documents.

Requirements

• Associate degree in Science with ≥ 7 years in a pharmaceutical laboratory setting.
• Bachelor of Science degree in Chemistry, Biology, or Engineering with ≥ 5 years in a pharmaceutical laboratory setting.
• Master of Science degree in Chemistry, Biology, or Engineering with ≥ 3 years in a pharmaceutical laboratory setting.

Benefits

• Inclusive and diverse workplace
• Equal Opportunity Employer
• Hybrid work model with three days on-site per week