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

Paid time off

401k savings plan

HSA

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Job summary

Cardinal Health, Inc. is seeking a Quality Control professional to perform inspections and analysis of materials and products in an onsite Indianapolis facility.

The role emphasizes adherence to regulatory standards and accurate testing across Drug Substance, in-process and drug product samples. The successful candidate will have a chemistry- or biology-related background, 2+ years in FDA-regulated settings, and strong technical writing skills to author SOPs and CAPAs, with proficiency in MS

Qualifications

• Bachelor’s degree or equivalent in chemistry or biology preferred.
• 2+ years of experience in FDA-regulated environment (21 CFR 210/211).
• Experience authoring SOPs, Change Controls, CAPAs, Deviations and Lab Investigations.
• Proficient in Microsoft Word and Excel; strong technical writing skills.

Responsibilities

• Conduct inspections and analysis of 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 worksheets and related documents.
• Train others on SOPs and instruments as needed.
• Stay aligned with supervisor on priorities.

Skills

Attention to detail

Technical writing

Team collaboration

Regulatory knowledge 21 CFR 210/211

Analytical testing methods

Education

Bachelor’s degree or equivalent in chemistry or biology

Tools

MS Word

MS Excel

Job description

Cardinal Health, Inc. is seeking a Quality Control professional to perform inspections and analysis of materials and products in an onsite Indianapolis facility.

The role emphasizes adherence to regulatory standards and accurate testing across Drug Substance, in-process and drug product samples. The successful candidate will have a chemistry- or biology-related background, 2+ years in FDA-regulated settings, and strong technical writing skills to author SOPs and CAPAs, with proficiency in MS