Senior QC Chemist II: Method Validation & Stability

Cardinal Health, Inc.; Legendary Hills (IN); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Health savings account

Job summary

Cardinal Health in Indianapolis, IN seeks a Quality Control professional to inspect materials, perform analyses, and ensure compliance with regulatory standards. The role emphasizes method validation, deviations management, and SOP/documentation duties in a radiopharmaceutical environment.

The position requires a chemistry/biology background with 2+ years in FDA-regulated settings, strong writing and teamwork skills, and proficiency in Word/Excel.

Qualifications

• Bachelor’s degree in chemistry or biology preferred or related field.
• 2+ years of experience in FDA-regulated industry (pharma/medical device).
• Knowledge of GDP documentation practices and requirements.
• Experience authoring SOPs, Change Controls, CAPAs, Deviations and Lab Investigations.
• Must work well in a team and be detail oriented.
• Proficient in Microsoft Word and Microsoft Excel; strong writing skills.

Responsibilities

• Inspect incoming materials, Drug Substance, In-Process and Drug Product samples.
• Perform investigations, deviations, change controls and CAPAs.
• Execute method verification, validation and/or transfer protocols.
• Perform stability testing per stability protocol at prescribed cadence.
• Author SOPs, analytical method worksheets and related documents.
• May train others on SOPs, PROTOCOLs, instruments and quality guidelines.
• Align work priorities with supervisor/management.
• Collaborate with other departments to understand interactions with Quality Control.

Skills

Detail oriented

Organized

Multitask

Self-starter

Self-motivated

Communication skills

Technical writing

Education

Bachelor's degree in chemistry/biology

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health in Indianapolis, IN seeks a Quality Control professional to inspect materials, perform analyses, and ensure compliance with regulatory standards. The role emphasizes method validation, deviations management, and SOP/documentation duties in a radiopharmaceutical environment.

The position requires a chemistry/biology background with 2+ years in FDA-regulated settings, strong writing and teamwork skills, and proficiency in Word/Excel.