Senior QC Chemist: Analysis, Validation & CAPA

HITEC; Indianapolis (IN); Hybrid; USD 69,000 - 88,000; 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

Job summary

Cardinal Health is seeking a Quality Control professional to oversee inspections of raw materials and product samples, and to execute verification and validation protocols within a radiopharmaceutical manufacturing setting.

The role involves stability testing, SOP drafting, and collaboration across departments. Ideal candidates have a chemistry or biology background, 2+ years in FDA-regulated environments, and strong analytical writing skills.

Qualifications

• Bachelor’s degree in chemistry or biology or related field preferred.

Responsibilities

• Perform inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples.
• Execute method verification, validation and/or transfer protocols.
• Perform stability testing per stability protocol at the prescribed cadence.
• Author SOPs, analytical method worksheets, forms and related documents.
• Adhere to policies and procedures and maintain regulatory compliance.
• May train others on SOPs, PROTOCOLs, instruments and quality guidelines.
• Exhibit attention to detail and strong organization.

Skills

Teamwork

Detail-oriented

Strong communication

Microsoft Word

Microsoft Excel

Technical writing

Self-starter

Education

Bachelor’s degree in chemistry or biology

Tools

Microsoft Word

Microsoft Excel

Documentation systems

Job description

Cardinal Health is seeking a Quality Control professional to oversee inspections of raw materials and product samples, and to execute verification and validation protocols within a radiopharmaceutical manufacturing setting.

The role involves stability testing, SOP drafting, and collaboration across departments. Ideal candidates have a chemistry or biology background, 2+ years in FDA-regulated environments, and strong analytical writing skills.