Senior Specialist - Quality Assurance - Nights jobs in United States
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Cardinal Health · 2 weeks ago

Senior Specialist - Quality Assurance - Nights

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. The Senior Specialist in Quality Assurance will develop and implement a compliant quality system, ensuring products are reliable, safe, and effective while collaborating with operations to drive quality standards.

Health CareHospitalMedical
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H1B Sponsor Likelynote

Responsibilities

Quality Assurance responsibilities include but are not limited to CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls
Establish and report metrics related products and processes as deemed necessary by the RQM
Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP)
Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities
Engage and collaboration with operations department to drive quality system and CGMP requirements
Responsible for product release activities per CGMP requirements
Responsible for reporting quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification

Qualification

Quality AssuranceCGMPRoot Cause AnalysisISO ExperiencePharmaceutical ExperienceMulti-taskingJudgmentEffective Communication

Required

Must be able to work NIGHTS
Effective written and verbal English communication skills required
Lifting: Frequent lifting between 50-75 lbs
Ability to manage several tasks at the same time
Ability to focus on tasks
Ability to evaluate operating conditions
Ability to exercise sound judgment

Preferred

Bachelor's of Science in Chemistry or Biology degree preferred
1-2 years experience in QA and/or regulated environment highly preferred - cGMP
Pharmaceutical or medical device experience a plus
ISO experience a plus
Quality Assurance background 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

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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 Company
Total Funding
$1.08B
2025-08-28Post Ipo Debt· $1B
2006-08-16Post Ipo Debt· $78M
1983-08-12IPO

Leadership Team

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Aaron Alt
Chief Financial Officer
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Tony Caprio
Executive Vice President
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Company data provided by crunchbase