Batch Record Review (Sr. Chemist) - 2nd Shift

Cardinal Health•Indianapolis, IN

9d•Onsite

About The Position

Nuclear Manufacturing is responsible for the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e. FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring. This role is responsible for assisting in batch record preparation and execution, reviewing and signing batch records and manufacturing documents/procedures as needed. The position supports Operations, Quality Control, Quality Assurance and Program Management teams by providing expertise and ensuring process documentation supports compliance. This role also assists in process improvements, gathering of metrics and data for review, and 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. Assists other production areas as needed.

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
Experience with GMP/GDP preferred
Experience with SAP preferred
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

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