C&Q Coordinator jobs in United States
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i-Pharm GxP · 14 hours ago

C&Q Coordinator

positionIndianapolis, IN
timeContract
remoteOnsite
seniorityEntry, Mid Level

i-Pharm GxP is seeking a C&Q Quality Coordinator to support commissioning and qualification activities on a major capital project. This role focuses on execution quality and standardization, ensuring alignment between CQV, site QA, and construction/start-up teams for effective protocol execution.

Management Consulting
Hiring Manager
Harry Reeve
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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
Installation Verification (IV)
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

Qualification

Commissioning & QualificationProtocol execution qualityKneatSimilar systemsRegulated / GxP environmentsQuality AssuranceValidationInspection readinessAudit support

Required

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

Preferred

Background in Quality Assurance, Validation, or Engineering
Experience on large Greenfield or Brownfield projects
Exposure to inspection readiness and audit support activities

Company

i-Pharm GxP

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Consulting Services to scope, staff, manage and deliver GxP solutions across North America, Europe and the Asia-Pacific.
dateFounded in 2014
location
Charlotte, North Carolina, US
people-size11-50 employees
web-link
https://www.i-pharmgxp.com/

Funding

Current Stage
Early Stage
Company data provided by crunchbase