Specialist – Stability & Sample Management

Merck Merck · Pharma · NJ

This role supports GMP stability and sample management logistics within the Research Laboratories Division, collaborating with analytical scientists and managing analytical samples for stability studies. Responsibilities include receiving, aliquoting, preparing, and shipping samples, maintaining accurate records using digital systems like LIMS, and managing deviations and change controls. The role requires experience in a GMP environment and strong collaboration skills.

What you'd actually do

  1. Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence.
  2. Receive analytical samples from partner groups according to established procedures.
  3. Perform deviations and investigations, create Change Management records (where necessary), manage GMP documentation including Standard Operating Procedures (SOP).
  4. Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems (e.g., LIMS, Benchling, electronic notebook, eLogs).
  5. Stability study builds in LIMS and data management.

Skills

Required

  • Collaboration
  • GMP environment
  • GMP policies and procedures
  • Sample Management
  • Inventory Management
  • LIMS
  • Change Management
  • Deviation Management
  • SOP Writing

Nice to have

  • Auditing and Compliance
  • Quality Auditing
  • Team Leadership

What the JD emphasized

  • GMP environment
  • GMP policies and procedures