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 activities
Engages and collaborates with operations department to drive quality system and CGMP requirements
Perform product release activities per CGMP requirements
Report quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification.
Schedule
Onsite in Van Nuys, CA
40 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.
Effective written and verbal English communication skills
Ability to manage several tasks at the same time
Pharmaceutical or medical device experience a plus
ISO experience a plus
Ability 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 tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes action to resolve
Applies judgment within defined parameters
Receives general guidance and may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy
Anticipated 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 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
Application window anticipated to close: 01/10/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate?s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges – now, and in the future.As a global, growing company, we’re able to offer rewarding careers that let you make a positive impact on our customers and communities.
