Scientist I, Pharmaceutical Analysts

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 incumbents 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.

Qualifications

• Bachelors 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.

Anticipated hourly range:$31.50 per hour - $38.46 per hour

Bonus eligible:No

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

• 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:1/2/2026 *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.

#LI-MP1

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.

To read and review this privacy notice click here