Specialist, Data Services

Merck & Co. - Wilson, NC

Full-time - Mid Level

Onsite - Wilson, NC

1,001-5,000 employees

Chemical Manufacturing

About the position

The QC Data Services Specialist is responsible for stability laboratory data review, stability data requests, analytical standard updates, review of site Annual Product Reviews (APR), data trending, and support of Quality Notifications and CAPAs. This role requires mastery of data management and documentation programs and ensures compliance with FDA & GMP regulations while maintaining positive site relations.

Responsibilities

• Conduct stability laboratory data review and manage stability data requests.
• Update analytical standards and review site APR.
• Perform data trending and support Quality Notifications and CAPAs.
• Work independently and collaboratively to achieve site goals.
• Initiate and lead problem-solving efforts to prevent reoccurrence of issues.
• Timely approval of qualification, change control, and other documents.
• Support GLIMS updates and review builds and specifications.
• Attend departmental meetings focused on stability data review and reporting.
• Serve as a liaison between teams and external entities regarding quality policies.
• Participate in internal and external audits and inspections.

Requirements

• Associate degree in Science with 4 years in a pharmaceutical laboratory setting or a Bachelor of Science degree in Chemistry, Biology, or Engineering with 2 years in a pharmaceutical laboratory setting.
• Demonstrated ability to influence teams and be a recognized resource.
• Deep understanding of customer needs and regulatory compliance requirements.

Nice-to-haves

• Experience with GLIMS, MEDS, IPI, SAP, and other data management systems.
• Knowledge of Root Cause Analysis tools and quality investigation processes.

Benefits

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