What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.
Responsibilities Handles 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 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 activitiesEngages and collaborates with operations department to drive quality system and CGMP requirementsPerform product release activities per CGMP requirementsReport quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification.Schedule Onsite in Van Nuys, CA40 hours per week. This is a night position. Typically, Monday – Friday between 1:00 am - 9:30 am and every other Saturday per month. Saturday shift is typically a few hours. Candidate must be flexible to work different shifts or schedules based on business need. Candidate must be comfortable staying until work is completed each business day. Work hours may be subject to change.Qualifications Bachelor's degree in related field (science) preferred, or equivalent work experience preferred.2+ years of experience in related field preferred1-2 years' experience in Quality Assurance and/or cGMP regulated environment preferredEffective written and verbal English communication skillsAbility to manage several tasks at the same timePharmaceutical or medical device experience a plusISO experience a plusAbility to lift up to 30-45 lbs.Work Environment The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.What is expected of you and others at this level Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasksWorks on projects of moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes action to resolveApplies judgment within defined parametersReceives general guidance and may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracyAnticipated salary range:$75,600-$108,000
Bonus eligible:No
Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close:01/10/2025 *if interested in opportunity, please submit application as soon as possible.
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