Scientist I, Pharmaceutical Analysts

Cardinal Health•Mansfield, MA

1d•$32 - $38•Onsite

About The Position

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. Below are Responsibilities and requirements for the Position of Quality Control Specialist (P1) at a Quality Organization. This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA. Responsibilities Provide Quality Control review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards Thoroughly review analytical data generated from tests, identifying any deviations from expected results, and investigating potential causes. Ensure adherence to Good Manufacturing Practices (GMP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols. Review and approve stability studies, and other relevant documentation to ensure accuracy and compliance. Actively support stability studies and collaborate across departments to ensure product integrity and shelf-life requirements are met. Review stability data trending, statistical analysis, and interpretation to assess product degradation and predict shelf-life. Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership. Collaborate with QA analytical teams to ensure product quality throughout the stability test process. Support & evaluate change controls. Assist QA management, oversee the stability study lifecycle, including protocol Stay current with industry regulations, guidelines, and best practices. Assist in the preparation and execution of regulatory inspections and audits. What is expected of you and others at this level Provide Quality Control 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. Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing. Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures. Work with QA management, establishes, implements, and achieves a Professional Development Plan that maintains the incumbent’s high level of scientific and regulatory knowledge and expertise. Demonstrated initiative – able to work proactively with direct supervision and with a continuous improvement mind-set.

Requirements

Bachelor's degree in chemistry 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.
0-2 years of experience in quality control 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 a plus.
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, preferred.
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.
Experience with Quality Management Software (QMS), such as Trackwise, Veeva or Agile and Laboratory Information Management System (LIMS), such as LabWare.
Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing.
Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures.

Responsibilities

Provide Quality Control review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards
Thoroughly review analytical data generated from tests, identifying any deviations from expected results, and investigating potential causes.
Ensure adherence to Good Manufacturing Practices (GMP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols.
Review and approve stability studies, and other relevant documentation to ensure accuracy and compliance.
Actively support stability studies and collaborate across departments to ensure product integrity and shelf-life requirements are met.
Review stability data trending, statistical analysis, and interpretation to assess product degradation and predict shelf-life.
Identify and communicate stability trends, deviations, or out-of-specification results to QA leadership.
Collaborate with QA analytical teams to ensure product quality throughout the stability test process.
Support & evaluate change controls.
Assist QA management, oversee the stability study lifecycle, including protocol
Stay current with industry regulations, guidelines, and best practices.
Assist in the preparation and execution of regulatory inspections and audits.
Provide Quality Control review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards
Work with QA management, establishes, implements, and achieves a Professional Development Plan that maintains the incumbent’s high level of scientific and regulatory knowledge and expertise.
Demonstrated initiative – able to work proactively with direct supervision and with a continuous improvement mind-set.