Quality Data Specialist — Stability & Compliance

MSD Malaysia; Wilson (NC); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck & Co., Inc., Rahway, NJ, USA seeks a Growth and Improvement-minded Data Services Specialist in Quality Control to drive strategic priorities. The role focuses on stability data review, site release, and support of quality notifications and CAPAs within a GMP environment.

Typical responsibilities include data management across GLIMS, MEDS, IPI, and SAP, plus collaboration with NASU teams and external entities to ensure compliance and data integrity in pharmaceutical manufacturing.

Qualifications

• Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting.

Responsibilities

• Stability data review and plant site release.
• Review of site APR and data trending.
• Support of Quality Notifications and CAPAs.
• Liaise between NASU teams and external entities; ensure compliance with GMP.

Skills

Adaptability

Analytical Instrumentation

Analytical Method Development

Dissolution Testing

Driving Continuous Improvement

GMP Compliance

Karl Fischer Titrations

Laboratory Documentation

Laboratory Safety

Microbiological Analysis

Microbiological Test

Teamwork

Technical Writing

Troubleshooting

Use of Laboratory Equipment

Education

Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting

Tools

GLIMS

MEDS

IPI

SAP

Job description

Merck & Co., Inc., Rahway, NJ, USA seeks a Growth and Improvement-minded Data Services Specialist in Quality Control to drive strategic priorities. The role focuses on stability data review, site release, and support of quality notifications and CAPAs within a GMP environment.

Typical responsibilities include data management across GLIMS, MEDS, IPI, and SAP, plus collaboration with NASU teams and external entities to ensure compliance and data integrity in pharmaceutical manufacturing.