Senior QC Chemistry Specialist — 2nd Shift

cardinalhealth; Indianapolis (IN); On-site; USD 81,000 - 116,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health in Indianapolis seeks a Principal Specialist, Quality Control (Chemistry) to lead analytical testing, ensuring compliance with regulatory standards and internal specs. You will mentor staff, develop SOPs, and oversee method verification and validation in a radiopharmaceutical setting.

This role requires a Bachelor’s degree in a related science and 5+ years in FDA-regulated QC chemistry, plus strong documentation and communication skills to drive quality improvements.

Qualifications

• Bachelor’s degree or equivalent in a science field.
• 5+ years of experience in FDA-regulated QC chemistry (21 CFR 210/211).
• Authoring SOPs, Change Controls, CAPAs, Deviations and Investigations.
• Strong technical writing and documentation skills.

Responsibilities

• Performs analysis of incoming materials, in-process, and product samples.
• Serves as a technical mentor and trainer in the chemistry department.
• Lead/facilitate qualification of analytical instrumentation.
• Execute method verification, validation or transfer protocols and instrument qualification scripts.
• Perform stability testing per prescribed cadence.
• Address investigations, deviations and CAPAs as needed.
• Author/optimize SOPs and testing forms; serve as SME for testing, instrumentation, and processes.
• Collaborate with multiple departments to coordinate analysis and projects.
• Champion quality, cGMP compliance, and EHS/radiation safety.
• Perform other duties as assigned.

Skills

Quality Control chemistry

Regulatory compliance

Technical writing

Training/mentoring

Analytical testing

Education

Bachelor’s degree or related science field

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health in Indianapolis seeks a Principal Specialist, Quality Control (Chemistry) to lead analytical testing, ensuring compliance with regulatory standards and internal specs. You will mentor staff, develop SOPs, and oversee method verification and validation in a radiopharmaceutical setting.

This role requires a Bachelor’s degree in a related science and 5+ years in FDA-regulated QC chemistry, plus strong documentation and communication skills to drive quality improvements.