Weekend QC Chemistry Principal Specialist & SME

Cardinal Health

Indianapolis (IN)

On-site

USD 82,000 - 105,000

Full time

4 days ago

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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

Long-term disability

Job summary

Cardinal Health is seeking a Principal Specialist in Quality Control (Chemistry) for the weekend shift in Indianapolis. The role leads analytical testing and method validation in a radiopharmaceutical manufacturing setting, ensuring compliance with 21 CFR and company SOPs.

Strong communication and SME-level expertise are essential to guide cross-functional teams. The position requires a Bachelor’s degree or equivalent experience with 5+ years in a regulated environment and proficiency in

Qualifications

Bachelor’s degree or related science field with 5+ years in FDA-regulated industry (Pharma/Medical Device).
Experience authoring SOPs, Change Controls, CAPAs, Deviations, and Lab Investigations.
Proficient in Word/Excel with strong technical writing skills.

Responsibilities

Performs analysis of incoming materials, in-process, and product samples.
Serves as a technical mentor and training to personnel in the chemistry department.
Lead qualification of analytical instrumentation.
Executes method verification/validation and transfer protocols.
Performs stability testing per stability protocols.
Authors and optimizes SOPs and testing forms.
Acts as SME for analytical testing/instrumentation.
Collaborates with multiple departments on projects.
Champions quality, cGMP compliance, and EHS/Radiation Safety.
Performs other duties as assigned.