Senior QC Chemist II — Precision Analysis & Impact

cardinalhealth; Indianapolis (IN); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Access to wages before pay day with my

Flexible spending accounts

Job summary

Cardinal Health is seeking a Quality Control professional to lead analysis of incoming materials, drug substances, and product samples within a radiopharmaceutical manufacturing environment.

The role emphasizes adherence to regulatory standards, execution of method verification and stability testing, and collaboration with cross-functional teams to ensure product quality and process improvement.

Qualifications

• Bachelor's degree in chemistry or biology preferred or equivalent work experience.
• 2+ years of relevant experience in FDA-regulated industry (Pharmaceutical/Medical Device).
• Knowledge of GDP documentation practices and requirements.
• Experience drafting SOPs, Change Controls, CAPAs, deviations and Lab Investigations.
• Strong teamwork and communication skills.
• Detail oriented, organized, multitasking.
• Proficient in Word and Excel with strong technical writing skills.
• Demonstrated collaboration and teamwork.

Responsibilities

• Inspect incoming materials, Drug Substance, In-Process and Drug Product samples.
• Perform investigations, deviations, change controls and CAPAs.
• Execute method verification, validation and transfer protocols.
• Perform stability testing per protocol.
• Draft SOPs and required forms.
• Maintain compliance with regulatory standards.
• Align priorities with supervisor and other departments.
• Possibly train others on SOPs and instruments.

Skills

FDA regulations (21 CFR 210/211)

Strong communications

Team collaboration

Education

Bachelor's degree in chemistry or biology preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health is seeking a Quality Control professional to lead analysis of incoming materials, drug substances, and product samples within a radiopharmaceutical manufacturing environment.

The role emphasizes adherence to regulatory standards, execution of method verification and stability testing, and collaboration with cross-functional teams to ensure product quality and process improvement.