Quality Control Specialist

Cardinal Health•Mansfield, MA

13d•$30 - $43•Onsite

About The Position

Scientific Services Chemistry Center (SSCC) performs laboratory testing to characterize the chemistry of our medical device products and stability testing for pharmaceutical products of 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 will also use specialized instruments to perform Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceutical. 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 Control Specialist executes quality programs, policies, and procedures in a particular area of specialty in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance and quality control concepts, the Specialist review data and creates reports on quality metrics and trends in support of resolutions to quality issues and 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.

Requirements

Bachelor's degree in related field, or equivalent work experience, preferred
0-2 years of experience, preferred.
Basic knowledge of quality assurance and quality control concepts.
Knowledge of USP, FDA, and ICH regulatory requirements pertinent to pharmaceutical stability testing preferred.
Basic understanding and application of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) preferred.
Experience with Quality Management Software (QMS) (e.g., Veeva, Agile) and Laboratory Information Management Systems (LIMS) (e.g., LabWare) preferred.
Applies 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.

Responsibilities

Provide Quality review and analysis of data specifically from pharmaceutical stability studies to ensure compliance with established quality standards and regulatory requirements.
Thoroughly review analytical data generated from tests, identifying any deviations or out-of-specification results, and communicating directly to Quality Assurance (QA) leadership.
Ensure rigorous adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols.
Perform review and approval of stability studies, SOPs, protocols, and other relevant quality system documentation to ensure accuracy and compliance.
Actively support Quality Assurance management in the oversight of pharmaceutical stability studies and collaborate across departments to ensure product integrity and shelf-life requirements are met for pharmaceutical products.
Collaborate with cross-functional teams to ensure product quality throughout the pharmaceutical stability test process.
Support and evaluate change controls related to pharmaceutical testing.
Assist in the preparation for and execution of regulatory inspections and internal audits.
Supports the Quality Assurance Manager in quality audits and inspections of distribution centers within the region.
Record quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.
Partners with Senior or Principal Specialist on complex regulatory submissions, operational recommendations, product analyses, and other tasks in order to develop advanced knowledge of relevant regulations and internal processes.