Associate Specialist, Operations

Merck Merck · Pharma · KS

This role supports antigen production operations in a pharmaceutical manufacturing setting, focusing on technical and operational support to ensure manufacturing schedules are met in a compliant manner with safety, quality, and regulatory requirements. Responsibilities include ensuring product specifications are met, managing deviations and changes, and supporting continuous improvement initiatives.

What you'd actually do

  1. The Operations Associate Specialist, in conjunction with the execution routine production activities, will primarily support the team by acting as a Subject Matter Expert (SME) representing their department in support of continuous improvement, transfer of new products, problem solving, as well as deviation and change management.
  2. This position provides technical and operations support to assure that manufacturing schedules are met in a compliant manner with safety, quality, and regulatory requirements.
  3. Responsibilities include that antigen products specifications are met prior to release for compliance to product Outlines, United States Department of Agriculture 9 Code of Federal Regulations, and cGMP.
  4. On-time completion of Quality compliance tasks in relation to Deviation, CAPA and Change Control management.
  5. Supports the Manufacturing Operations Teams in creating a culture of continuous improvement and leads by example

Skills

Required

  • Adverse Event Reporting System
  • Autoclaving
  • Buffer Preparation
  • Cell Culture Process Development
  • Change Management
  • Collaborative Development
  • Customer Service Operations
  • Detail-Oriented
  • Driving Continuous Improvement
  • Fermentation Process Development
  • Fermentation Tanks
  • Filtering Equipment
  • Global Manufacturing
  • GMP Compliance
  • Liquid Chromatography (LC)
  • Media Preparation
  • Monoclonal Antibodies
  • Operations Support
  • Pharmaceutical Manufacturing
  • Polyclonal Antibody Production
  • Process Control
  • Production Scheduling
  • Quality Assurance (QA)
  • Recruitment Operations

Nice to have

  • BSc Degree in a relevant scientific discipline
  • experience working within a Pharmaceutical Manufacturing role

What the JD emphasized

  • Safety First, Quality Always
  • cGMP
  • United States Department of Agriculture 9 Code of Federal Regulations