Associate Specialist, Operations

Merck Merck · Pharma · KS

This role supports manufacturing operations in a pharmaceutical setting, focusing on continuous improvement, problem-solving, and managing deviations and changes. It involves ensuring safety and quality compliance, supporting production schedules, and collaborating with various stakeholders. The role requires a high school diploma and pharmaceutical manufacturing experience, or a BS degree with relevant experience. It emphasizes adherence to cGMP, Lean Six Sigma, and Project Management principles.

What you'd actually do

  1. Acts as a Subject Matter Expert (SME) representing their department in support of continuous improvement, problem solving and deviation and change management.
  2. Demonstrates a strong compliance mind-set (EHS and Quality) and continuously sets a high standard for themselves and others.
  3. Is responsible for the on-time completion of Quality compliance tasks in relation to Deviation, CAPA and Change Control management.
  4. Supports the Daily, Weekly and Monthly schedule adherence of production activities within their department.
  5. Assures effective application of Lean Six Sigma, Project Management and Change Management Tools.

Skills

Required

  • Adverse Event Reporting System
  • Autoclaving
  • Buffer Preparation
  • Cell Culture Process Development
  • Customer Service Operations
  • Detail-Oriented
  • Fermentation Process Development
  • Fermentation Tanks
  • Filtering Equipment
  • Liquid Chromatography (LC)
  • Media Preparation
  • Process Control
  • Production Scheduling
  • Safety Practices
  • Standard Operating Procedure (SOP) Writing

What the JD emphasized

  • Pharmaceutical Manufacturing role
  • cGMP