QC Chemistry Lead, 2nd Shift – SME & Process Improvement

Cardinal Health; Indianapolis, Northern (IN, KY); Hybrid; USD 81,000 - 116,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Short- and long-term disability

Job summary

Cardinal Health is seeking a Principal Specialist, Quality Control (Chemistry) for the 2nd shift in Indianapolis, IN. You will lead technical aspects of QC testing, mentor staff, and ensure compliance with 21 CFR 210/211, cGMP and safety standards.

The role requires a Bachelor’s degree or equivalent in science, 5+ years of FDA-regulated industry experience, and strong documentation skills. You will collaborate across departments on investigations, CAPAs and validations.

Qualifications

• Bachelor’s degree or equivalent in a related science field preferred.
• 5+ years of experience in FDA regulated industry (21 CFR 210, 211).
• Strong technical writing skills and experience authoring SOPs, Change Controls, CAPAs, Deviations and Lab Investigations.

Responsibilities

• Analyze incoming materials, in-process samples and finished products.
• Serve as SME and mentor personnel in the chemistry department.
• Lead qualification of analytical instrumentation and instrument qualification protocols.
• Execute method verification, validation, and transfer protocols and computer system validation tests.
• Perform stability testing per approved protocols and investigate deviations and CAPAs as needed.
• Author and optimize SOPs and testing forms; coordinate with multiple departments on projects.

Skills

Quality control

Documentation

Regulatory knowledge

Education

Bachelor’s degree or equivalent in science

Tools

MS Word

MS Excel

Job description

Cardinal Health is seeking a Principal Specialist, Quality Control (Chemistry) for the 2nd shift in Indianapolis, IN. You will lead technical aspects of QC testing, mentor staff, and ensure compliance with 21 CFR 210/211, cGMP and safety standards.

The role requires a Bachelor’s degree or equivalent in science, 5+ years of FDA-regulated industry experience, and strong documentation skills. You will collaborate across departments on investigations, CAPAs and validations.