Orano USA · 12 hours ago
QC Specialist
Brownsburg, IN
Full-time
Onsite
New Grad, Entry LevelOrano Med is seeking a detail-oriented QC Specialist to join our Quality Control team. In this role, you'll be responsible for incoming quality control (IQC) activities for raw materials while providing cross-functional support to QC Chemistry operations and managing externally executed raw material testing projects in a GMP pharmaceutical environment.
Utilities
Responsibilities
Perform receipt, sampling, testing, and release of raw materials in compliance with GMP, USP, Ph. Eur., and internal procedures
Execute compendial and non-compendial testing using approved analytical methods
Review data and release materials using established quality systems
Maintain raw material specifications, sampling plans, and test methods
Manage material status labeling, quarantine, and inventory controls
Support and investigate material-related deviations, OOS/OOT results, and discrepancies
Serve as QC liaison for external laboratories performing raw material testing, including protocol review, data review, and issue resolution
Crosstrain and support routine QC chemistry testing as needed to meet operational demand
Maintain GMP documentation, logbooks, and reports
Promote a culture of safety, quality, and continuous improvement across the team
Identify process inefficiencies and lead improvement initiatives
Qualification
Required
Detail-oriented
Experience in quality control (QC) activities for raw materials
Knowledge of GMP, USP, Ph. Eur., and internal procedures
Ability to perform receipt, sampling, testing, and release of raw materials
Experience executing compendial and non-compendial testing using approved analytical methods
Ability to review data and release materials using established quality systems
Experience maintaining raw material specifications, sampling plans, and test methods
Ability to manage material status labeling, quarantine, and inventory controls
Experience supporting and investigating material-related deviations, OOS/OOT results, and discrepancies
Ability to serve as QC liaison for external laboratories performing raw material testing
Experience with protocol review, data review, and issue resolution
Ability to crosstrain and support routine QC chemistry testing as needed
Experience maintaining GMP documentation, logbooks, and reports
Ability to promote a culture of safety, quality, and continuous improvement
Experience identifying process inefficiencies and leading improvement initiatives
Strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211; ICH; USP)
Company
Orano USA
U.S. advanced reactor services, uranium enrichment, uranium sales, used nuclear fuel management, federal services, and nuclear medicine.
Founded in 2017
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase