Specialist, Quality Assurance

What Scientific Services Chemistry Center contributes to Cardinal Health

Scientific Services Chemistry Centers (SSCC) performs laboratory testing to characterize the chemistry of our medical device products and stability testing for pharmaceutical products at Cardinal Health. Under the umbrella of Quality Regulatory and Medical Affairs (QRMA) SSCC develops and executes test protocols utilizing specialized instrumentation and analytical techniques to characterize medical devices materials and processing aids for chemical properties of concern or the chemical constituents which may be released when a device is utilized during clinical use. The SSCC also uses specialized instruments to perform assay and impurity/degradant tests for stability and release testing for solid dose pharmaceuticals. SSCC is a part of QRMA Scientific Services.

This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield MA.

Job Summary
The Quality Specialist executes quality programs policies and procedures in a particular area of specialty to minimize risks and drive data integrity. With basic knowledge of quality assurance and quality control concepts the Specialist reviews processes and documents and contributes to the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities.

Responsibilities

• Provide Quality Control review and analyze data from pharmaceutical stability studies to ensure compliance with established quality standards and regulatory requirements.

• Thoroughly review analytical data generated from analyses identifying any deviations or out-of-specification results and communicating directly with Quality Assurance (QA) leadership.

• Ensure adherence to Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) regulations.

• Perform review and approve stability studies SOPs protocols and other relevant quality system documentation to ensure accuracy and compliance.

• Review stability data trending statistical analysis and interpretation to assess product degradation and predict shelf-life.

• Support and evaluate change controls related to pharmaceutical testing.

• Stay current with industry regulations guidelines and best practices.

• Assist in the preparation for and execution of regulatory inspections and audits.

Qualifications

• Bachelors degree in chemistry pharmacy or a related scientific field preferred or relevant work experience.

• 0-2 years of experience in quality control within a pharmaceutical or biopharmaceutical manufacturing or testing environment preferred.

• Basic knowledge of quality assurance and quality control concepts.

• Experience with quality management systems (e.g. Veeva Agile) experience with LIMS (e.g. LabWare) is a plus.

• Ability to prioritize objectives from multiple projects adhere to scheduled timelines while maintaining flexibility.

• Excellent attention to detail.

• Strong communication (both oral and written) and reporting skills.

• Ability to work in a fast-paced cross-functional environment.

What is expected of you and others at this level

• Apply basic concepts principles and technical capabilities to perform routine tasks.

• Works on projects of limited scope and complexity.

• Follows established procedures to resolve readily identifiable technical problems.

• Works under direct supervision and receives detailed instructions.

• Develops competence by performing structured work assignments.

• Demonstrated initiative able to work proactively with direct supervision and with a continuous improvement mind-set.

Anticipated hourly range:$30.10 per hour - $38.61 per hour

Bonus eligible:No

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and wellbeing.

• 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:09/21/2026 *if interested in opportunity please submit application as soon as possible.

The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including but not limited to a candidates 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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