Stability Program Coordinator

Merck & Co., Inc., Rahway, NJ, USA

Rahway, New Jersey, USA
Not specified (assumed on-site due to the nature of the role)
Stability protocols and amendments
Ich guidelines
Glims verification
Merck & Co., Inc. is seeking a Stability Program Coordinator for their Rahway, NJ location. The role involves overseeing stability protocols and data management in compliance with regulatory standards, aiming to enhance the company's biopharmaceutical research efforts

Job Summary

  • We aspire to be the premier research-intensive biopharmaceutical company, at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.
  • Responsibilities include drafting, reviewing, and maintaining stability protocols, managing stability pull schedules, overseeing sample chain-of-custody, and compiling/interpreting stability data.
  • Ensure adherence to GMP, GDP, data integrity, and site/global SOPs, while investigating OOS/OOT/atypical trends and supporting audits.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking a Stability Program Coordinator for their Rahway, NJ location. The role involves overseeing stability protocols and data management in compliance with regulatory standards, aiming to enhance the company's biopharmaceutical research efforts.

Skills & Requirements

Must-have

  • stability protocols and amendments
  • ICH guidelines
  • GLIMS verification
  • data integrity
  • GMP, GDP, SOPs adherence
  • stability chambers and alarms

Nice-to-have

  • continuous quality/process improvement
  • interdependent work culture
  • digitalization efforts
  • harmonization with global standards

Key Requirements

  • 4 years' experience in biotech/pharma
  • Science/Technical/Quality degree
  • Understanding of cGMP for Lab Operations
  • Understanding of GMP, ICH, USP regulations

Work Rights

Not specified

Tailored Resume

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