Quality Control Data Services Specialist

Biopharma Careers

Kansas

On-site

USD 87,000 - 137,000

Full time

8 days ago

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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
401(k) retirement plan
Paid holidays
Vacation

Job summary

Merck & Co. is seeking a QC Data Services Specialist focused on growth and improvements in Quality Control. You will master data management tools and lead stability data review, site release activities, and CAPA support to ensure FDA and GMP compliance.

Collaborate with NASU, Global Support, and external sites to uphold high standards. The role emphasizes cross-functional teamwork, problem solving, and maintaining robust documentation using GLIMS, MEDS, IPI, and SAP.

Qualifications

  • Bachelor of Science degree in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting.
  • Experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.).

Responsibilities

  • Stability data review and plant site release.
  • Review of site APR (Annual Product Review).
  • Data trending and reporting.
  • Support of Quality Notifications and CAPAs.

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 in Chemistry/Biology/Engineering

Tools

GLIMS
MEDS
IPI
SAP

Job description

Merck & Co. is seeking a QC Data Services Specialist focused on growth and improvements in Quality Control. You will master data management tools and lead stability data review, site release activities, and CAPA support to ensure FDA and GMP compliance.

Collaborate with NASU, Global Support, and external sites to uphold high standards. The role emphasizes cross-functional teamwork, problem solving, and maintaining robust documentation using GLIMS, MEDS, IPI, and SAP.

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