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C&Q Coordinator

Job in Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: i-Pharm GxP
Full Time position
Listed on 2026-02-10
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, QA Specialist / Manager
  • Engineering
    Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below
Location: Indianapolis

We are seeking a C&Q Quality Coordinator to support commissioning and qualification activities on a major capital project. This role will focus on execution quality, standardisation, and alignment between CQV, site QA, and construction/start-up teams to ensure right-first-time protocol execution.

Key Responsibilities
  • Report to the CQ Verification SME
    , supporting quality oversight across commissioning and qualification activities
  • Assist in revising and maintaining project SOPs related to C&Q execution and documentation
  • Support the development of gold-standard execution examples for:
  • Start-Up
  • Shakedown
  • Operational Verification (OV)
  • Align closely with Site QA to define:
  • How execution examples are to be performed in the field
  • How supporting documents, evidence, and attachments are correctly linked within Kneat
  • Assist in training commissioning teams on correct protocol execution and documentation expectations
  • Support periodic reviews of executed C&Q protocols
    , identifying gaps, trends, and improvement opportunities
  • Promote consistent, compliant, and inspection-ready C&Q execution across all systems
Required Experience
  • Experience supporting Commissioning & Qualification (C&Q / CQV) activities on capital projects
  • Strong understanding of protocol execution quality
    , deviations, and documentation best practices
  • Familiarity working within regulated / GxP environments (Pharma, Biotech, Life Sciences preferred)
  • Hands-on experience with Kneat or similar electronic validation systems
  • Ability to work cross-functionally with CQV, QA, and construction/start-up teams
Nice to Have
  • Background in Quality Assurance, Validation, or Engineering
  • Experience on large Greenfield or Brownfield projects
  • Exposure to inspection readiness and audit support activities
Why Apply
  • Play a key role in improving execution quality on a high-profile CQV project
  • Work closely with senior CQV and QA stakeholders
  • Opportunity to influence standards and best practices across the project
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