Batch Record Review (Sr. Chemist)
Cardinal Health, Indianapolis, IN, United States
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
Anticipated salary range:
$68,500 - $88,020
Bonus eligible:
No
Benefits:
Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Application window anticipated to close:
06/21/2026 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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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
Anticipated salary range:
$68,500 - $88,020
Bonus eligible:
No
Benefits:
Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Application window anticipated to close:
06/21/2026 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
#J-18808-Ljbffr