Lead QC Chemistry Specialist, 2nd Shift

Cardinal Health; Indiana (PA); On-site; USD 81,000 - 116,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

HSA

Paid time off

MyFlexPay access

Job summary

Cardinal Health is seeking a Principal Specialist, Quality Control (Chemistry) to lead analytical testing and ensure product compliance within a radiopharmaceutical manufacturing facility. You will mentor staff, develop test methods, and maintain adherence to cGMP, regulatory standards, and safety guidelines.

The role reports to the Manager, Quality Control (Chemistry) and requires deep knowledge of analytical instrumentation, method validation, and CAPA processes.

Qualifications

• Bachelor’s degree or equivalent experience in science field.
• 5+ years in FDA-regulated pharma/medical device (21 CFR 210, 211)
• Experience in SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations
• Proficient in MS Word and Excel with strong technical writing skills

Responsibilities

• Performs analysis of incoming materials, in-process, and product samples.
• Leads training and mentoring in chemistry department.
• Leads qualification of analytical instrumentation.
• Executes method verification, validation, transfer protocols, instrument qualification, or computer system validation scripts.
• Performs stability testing per protocols.
• Conducts laboratory investigations, change controls, deviations, and CAPAs as needed.
• Authors and optimizes SOPs and testing documents.
• Acts as SME for analytical testing, instrumentation, or processes.
• Collaborates with multiple departments on projects.
• Champions quality, cGMP compliance, and EHS safety.

Skills

5+ years experience

FDA regulations 21 CFR 210/211

SOPs & CAPAs

MS Word & Excel

Education

Bachelor’s degree in science

Tools

Analytical instrumentation

Computer System Validation

Job description

Cardinal Health is seeking a Principal Specialist, Quality Control (Chemistry) to lead analytical testing and ensure product compliance within a radiopharmaceutical manufacturing facility. You will mentor staff, develop test methods, and maintain adherence to cGMP, regulatory standards, and safety guidelines.

The role reports to the Manager, Quality Control (Chemistry) and requires deep knowledge of analytical instrumentation, method validation, and CAPA processes.