Cardinal Health · 1 month ago
Senior Specialist, Quality Assurance
KY-Louisville PET
Full-time
Onsite
Mid, Senior Level
$68K/yr - $88K/yr
2+ years expCardinal Health is a leading healthcare services and products company, and they are seeking a Senior Specialist in Quality Assurance. The role involves performing quality reviews and approval decisions in an FDA-regulated drug manufacturing facility, ensuring compliance with regulatory standards and overseeing production activities.
Health CareHospitalMedical
Responsibilities
Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls
Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM
Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP)
Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities
Engages and collaborates with operations department to drive quality system and CGMP requirements
Performs product release activities per CGMP requirements
Monitors CAPA in investigations and closes when completed or escalates (if necessary)
Performs aseptic review of the site with operations and documents results
Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification
Qualification
Required
Proficiency with MS Excel and MS Word
Interpersonal skills
Attention to detail
Preferred
2-4 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred
Prior experience working nightshift, preferred
Prior experience maintaining a filing system, preferred
Project management, preferred
Prior experience in a cGMP environment, preferred
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.
10001+ employees
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
Leadership Team
Aaron Alt
Chief Financial Officer
T
Tony Caprio
Executive Vice President
Recent News
Morningstar.com
2026-01-16
Company data provided by crunchbase