Orano USA

QC Specialist

QC Specialist
Notice info
LocationBrownsburg, IN
Job Typefull time
On-site
Nuclear Electric Power Generation

About This Job

Orano 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.

Routine Functions – QC

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.

Other duties as assigned by Supervisor/Management

Continuous Improvement

Promote a culture of safety, quality, and continuous improvement across the team.

Identify process inefficiencies and lead improvement initiatives.

Maintain strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211; ICH; USP).

N/A, Orano 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.

Routine Functions – QC

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.

Other duties as assigned by Supervisor/Management

Continuous Improvement

Promote a culture of safety, quality, and continuous improvement across the team.

Identify process inefficiencies and lead improvement initiatives.

Maintain strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211; ICH; USP)., N/A

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