Lead Quality Control Data Reviewer

Cardinal Health, Inc.; Indianapolis (IN); On-site; USD 81,000 - 104,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

MyFlexPay access to wages

Job summary

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Control (Data Review) to lead technical QC activities and mentor staff in a radiopharmaceutical environment. The role focuses on analytical testing, method verification, and SOP development within a compliant, safety-conscious team.

The position requires expertise in 21 CFR 210/211, strong writing skills, and the ability to train others while driving continuous improvement in quality and regulatory adherence.

Qualifications

• Bachelor's degree or equivalent experience in a relevant science field.
• 4-8 years of experience in FDA regulated industry (21 CFR 210, 211).
• Experience authoring SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Proficient in Microsoft Word and Microsoft Excel; strong technical writing skills.

Responsibilities

• Analyze incoming materials, in-process, and product samples.
• Serve as SME for analytical testing, instrumentation, and processes.
• Lead qualification of analytical instrumentation and validation/transfer protocols.
• Perform stability testing and investigations; manage deviations and CAPAs as needed.
• Author and optimize SOPs and testing forms; support cross‑department projects.
• Champion Quality, cGMP, and EHS practices; assist with training.

Skills

Technical writing

Attention to detail

Education

Bachelor's degree or related field

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Control (Data Review) to lead technical QC activities and mentor staff in a radiopharmaceutical environment. The role focuses on analytical testing, method verification, and SOP development within a compliant, safety-conscious team.

The position requires expertise in 21 CFR 210/211, strong writing skills, and the ability to train others while driving continuous improvement in quality and regulatory adherence.