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.

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.

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.

Bachelor’s 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,