Specialist, Data Services

Merck KGaA Darmstadt Germany - Wilson, NC

Full-time - Entry Level

Onsite - Wilson, NC

Chemical Manufacturing

About the position

The QC Data Services Specialist is responsible for overseeing stability laboratory data review, managing stability data requests, and ensuring compliance with FDA and GMP regulations. This role involves collaboration with various teams to support quality notifications and corrective actions, while also demonstrating mastery of data management programs. The position is essential for maintaining positive site relations and ensuring the reliability of laboratory operations.

Responsibilities

• Conduct stability laboratory data review and manage stability data requests.
• Update analytical standards and review site Annual Product Reviews (APR).
• Perform data trending and support Quality Notifications and CAPAs.
• Demonstrate mastery of data management and documentation programs such as GLIMS, MEDS, IPI, and SAP.
• Initiate and lead problem-solving efforts to prevent reoccurrence of issues and reduce laboratory downtime.
• Timely approval of qualification, change control, procedures, and other documents.
• Serve as a liaison between NASU teams, leadership, and external entities regarding stability data.
• Participate in internal and external audits and inspections, identifying product-related data trends.

Requirements

• Associate degree in Science with at least 4 years of experience in a pharmaceutical laboratory setting, or a Bachelor of Science degree in Chemistry, Biology, or Engineering with at least 2 years of experience in a pharmaceutical laboratory setting.
• Deep understanding of customer needs, requirements, and expectations in a laboratory context.
• Ability to interpret and apply company quality policies and guidelines.

Nice-to-haves

• Experience with Root Cause Analysis tools for quality and safety events.
• Familiarity with regulatory compliance requirements, including GMP and NDA regulations.

Benefits

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