Quality Assurance 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 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 Laboratory Practices (GLP) 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. 

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. 

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. 

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

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 is desired. 

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 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. 

Anticipated hourly range: $29.30 per hour - $41.90 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: 8/1/2025 *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 candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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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.

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