What Chemistry contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Chemistry performs laboratory testing to characterize the chemical properties of our medical device and pharmaceutical products. This job family develops and executes test protocols using specialized instrumentation and analytical techniques to assess chemical properties of finished drug products, medical devices, materials, processing aids, and the chemical constituents which may be released when a device is used in a clinical setting as well as the stability of pharmaceutical products.
This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.
Responsibilities
Plan and schedule work according to laboratory needs.
Participate in laboratory budgets planning, including ordering equipment and supplies, ordering consumables, and tracking costs
Serves as a department representative in cross-functional working teams and/or working with outside customers to meet stability testing needs
Ensure all testing is conducted according to cGMP principles.
Review analytical method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA).
Participate in investigations of Out of Specification (OOS) test results as needed follow FDA guidelines.
Manage and maintain compliance with relevant regulatory requirements (e.g. ICH and FDA) related to testing and data documentation.
Maintain a clean, safe work environment, comply with safety policies, and dispose of waste according to local, state, and federal regulations.
Ensure that the laboratory equipment and instruments are in good working conditions to perform analytical testing and minimize down time.
Collaborate with cross-functional teams to discuss stability concerns and address issues.
Monitor, track, and publish metrics and react to key process performance indicators (KPI).
Identifies areas for improvement and drives projects to implement solutions.
Train and mentor chemists in the department for continued improvement in the areas of technical knowledge, productivities and regulations.
Qualifications
4-8 years of experience, preferred
Bachelor's degree in related field preferred or equivalent work experience.
Experience with Quality Management Software (QMS), such as Veeva or Agile and compliance software like Laboratory Information Management System (LIMS), such as LabWare, preferred
Prior experience leading a team of analysts and scheduling laboratory testing, preferred
Experience with authoring standard operating procedures (SOPs), work instructions, and other documentation contributing to continuous improvement initiatives, preferred
Strength in authoring and reviewing analytical method transfer, qualification and validation/verification protocols and reports, preferred
Possesses working knowledge of USP, FDA, and ICH and ISO regulatory requirements as applicable to pharmaceutical stability testing, preferred
Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures, preferred
Experience with pharmaceutical testing techniques such as HPLC, UV-vis spectroscopy, Karl Fischer titration, and dissolution preferred
What is expected of you and others at this level
Coordinates and supervises the daily activities of operations or business staff
Administers and exercises policies and procedures. Ensures employees operate within guidelines.
Decisions have a direct impact to work unit operations and customers
Frequently interacts with subordinates, customers, and peer groups at various management levels
Interactions normally involve information exchange and basic problem resolution
Anticipated salary range: $106,300 - $136,710
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: 7/24/2026 *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.
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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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