Quality Assurance Sr. Specialist

What Chemistry Services Center contributes to Cardinal Health 

Chemistry Services Center perform laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Under the umbrella of QRMA, Chem Services 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 Chemistry Service will also use specialized instruments to perform Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceutical.  Chemistry Services is a part of QRMA Scientific Services.  

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

Responsibilities 

• Provide Quality Assurance review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards  

• Review and approve stability studies, trending, and interpretation other relevant documentation to ensure accuracy, compliance, and to assess product for degradation and shelf-life prediction.

• Thoroughly review and interpret analytical data generated from tests, identifying any deviations from expected results, quality issues, including out-of-specification results and taking appropriate corrective actions (e/g CAPA) to mitigate risks. . 

• Ensure adherence to Good Laboratory Practices (GLP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols. 

• Assist QA management, oversee the stability study lifecycle, including protocol 

• Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership. 

• Participate in the preparation and execution of regulatory inspections and audits.  Participate in internal and external audits to assess quality systems and identify areas for improvement

• Perform risk assessments to identify potential quality issues and implement preventive measures.  

• Stay current with industry regulations, guidelines, and best practices. 

Qualifications 

• Bachelor’s degree in chemistry, pharmacy or a related scientific field, preferred or relevant work experience.

• Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, Karl Fisher and dissolution and related instrumentations, preferred   

• 2-4 years of experience in quality assurance within a pharmaceutical or biopharmaceutical manufacturing or testing environment, preferred

• Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory requirements, preferred

• Working knowledge of regulatory guidelines of analytical method verification, validation, and method transfer, preferred

• Experience with investigations of Out of Specification (OOS) per FDA guidelines, preferred

• Experience in technical writing to support writing, review, and approval of quality documents such as procedures, investigations, and audit responses, preferred

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

• Experience with pharmaceutical stability test analysis software for data management is a plus. 

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

• Excellent attention to detail and data analysis skills. 

• 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 

• Provide Quality Assurance review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards  

• Experience with Quality Management Software (QMS), such as Trackwise, Veeva or Agile and Laboratory Information Management System (LIMS), such as LabWare. 

• Work with lab managers of pharmaceutical analysis department, provide inputs for development of instrument testing protocol and methods, standard operating procedures (SOPs), work instructions and other instrument documentation. 

• Ensures that the necessary testing is performed according to the test specification, test method and working instructions and to ensure testing is completed in a t