Batch Record Review (Sr. Chemist)

What Nuclear Manufacturing contributes to Cardinal Health

Manufacturing is responsible for cost of production and maintenance activities including process improvement, supply chain management, quality assurance, employee safety and engagement, and environmental commitment.

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.

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

Qualifications

• 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

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.