Chemical/Pharmaceutical, Quality Assurance (NIGHTS)
About The Position
Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This role applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks. Works on projects of moderate scope and complexity, identifying possible solutions to a variety of technical problems and taking actions to resolve. Applies judgment within defined parameters and receives general guidance, with work reviewed for sound reasoning and accuracy.
Requirements
- 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.
- Must be able to work night shift. roughly 9pm – 9am (give or take a few hours – 8 hour shift) Sunday - Friday.
Nice To Haves
- Bachelor's of Science degree preferred.
- 0-2 years’ experience in a regulated environment preferred.
- Pharmaceutical or medical device experience a plus.
- ISO experience a plus.
- Quality Assurance background preferred.
Responsibilities
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
