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C&Q Coordinator
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-02-16
Listing for:
i-Pharm GxP
Full Time
position Listed on 2026-02-16
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager -
Engineering
Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below
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
- 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
- Background in Quality Assurance, Validation, or Engineering
- Experience on large Greenfield or Brownfield projects
- Exposure to inspection readiness and audit support activities
- 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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