Cardinal Health · 1 month ago
Scientist I, Pharmaceutical Analysts
Cardinal Health is a leading healthcare services and products company, and they are seeking a Scientist I in Pharmaceutical Analysts to join their Chemistry Services Center. This role involves performing laboratory testing to characterize medical device products and stability testing for pharmaceuticals, ensuring compliance with quality standards and regulations.
Health CareHospitalMedical
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
Qualification
Required
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
Preferred
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
Benefits
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
Company
Cardinal Health
Cardinal Health is a manufacturer and distributor of medical and laboratory products.
H1B Sponsorship
Cardinal Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (128)
2024 (116)
2023 (140)
2022 (158)
2021 (106)
2020 (142)
Funding
Current Stage
Public CompanyTotal Funding
$1.08B2025-08-28Post Ipo Debt· $1B
2006-08-16Post Ipo Debt· $78M
1983-08-12IPO
Recent News
Morningstar.com
2026-01-16
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