Senior QC Chemistry Specialist, 2nd Shift

Cardinal Health, Inc.; Indianapolis (IN); On-site; USD 81,000 - 116,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k plan

Paid time off

HSA

Flexible spending accounts

Disability insurance

Work-Life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health, Inc. seeks a Principal Specialist, Quality Control (Chemistry) to lead technical activities, mentor staff, and ensure testing, documentation, and compliance align with regulatory standards.

Responsibilities include method verification/validation, instrumentation qualification, stability testing, and continuous process improvement in a radiopharmaceutical lab environment.

Qualifications

• Bachelor's degree or equivalent in a related science field preferred.
• 5+ years of experience in FDA regulated environments (Pharma/Medical Device).
• Experience authoring SOPs, change controls, CAPAs, deviations, and investigations.
• Strong technical writing and documentation skills.

Responsibilities

• Performs analysis of incoming materials, in-process, and product samples.
• Mentors personnel in the chemistry department.
• Leads qualification of analytical instrumentation.
• Executes verification/validation/transfer protocols and equipment qualification tests.
• Performs stability testing per cadence and investigations as needed.
• Authors and optimizes SOPs and testing forms.
• Acts as SME for analytical testing, instrumentation, and processes.
• Champions QA, cGMP compliance, and EHS practices.

Skills

Quality Control

gXP compliance

Technical writing

SOPs

Regulatory awareness

Team collaboration

Education

Bachelor's degree in science

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health, Inc. seeks a Principal Specialist, Quality Control (Chemistry) to lead technical activities, mentor staff, and ensure testing, documentation, and compliance align with regulatory standards.

Responsibilities include method verification/validation, instrumentation qualification, stability testing, and continuous process improvement in a radiopharmaceutical lab environment.