Batch Record Review (Sr. Chemist)

Cardinal Health•Indianapolis, IN

22h•Onsite

About The Position

Nuclear Manufacturing at Cardinal Health is responsible for the cost of production and maintenance activities, including process improvement, supply chain management, quality assurance, employee safety and engagement, and environmental commitment. This department manufactures time-sensitive radiopharmaceuticals in a highly regulated environment (FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring. At this level, the individual is expected to apply working knowledge of concepts, principles, and technical capabilities to perform varied tasks. They will work on projects of moderate scope and complexity, identify possible solutions to technical problems, and take action to resolve them. The role requires applying judgment within defined parameters, receiving general guidance, and potentially more detailed instruction on new projects. Work will be reviewed for sound reasoning and accuracy.

Requirements

Bachelor's degree in related field, or equivalent work experience, preferred
At least 2 years of experience working with 21CFR 210, 211 in the FDA regulated industry preferred
Must work well with others and understand how to be successful in a team environment
Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated
Must be proficient in Microsoft Office and possess strong technical writing skills
Excellent communication and interpersonal skills

Nice To Haves

Experience with GMP/GDP preferred
Experience with SAP preferred

Responsibilities

Responsible for assisting in batch record preparation and execution.
Review and sign batch records and manufacturing documents/ procedures as needed
Supports Operations, Quality Control, Quality Assurance and Program Management teams by providing expertise and ensuring process documentation supports compliance.
Assist in process improvements and gathering of metrics and data for review
Assist with the resolution of Non-Conformance Reports (NCRs) by investigating root causes, implementing corrective actions, and ensuring process adjustments prevent recurrence.
Assists with investigations of Corrective and Preventive Actions (CAPAs) related to process deviations, quality issues, and operational improvements, ensuring timely and effective closure.
May contribute to the development of policies and procedures directly impacting radiopharmaceutical operations and process control.
Assist other production areas as needed