Job Information
Cardinal Health Senior Specialist, Quality Assurance (PET) in Rochester, New York
Summary
Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. 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 Quality Assurance contributes to Cardinal Health
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
Demonstrates knowledge of quality systems and approaches.
Demonstrates an understanding of the relevant regulations, standards and operating procedures.
Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
Demonstrates ability to review and disposition documentation in a timely manner, such as: manufacturing batch records, EM records, validation documentation, change controls, process qualifications, on-site material preparations, equipment qualifications and/or planned maintenance, material acceptance, cleaning documents, etc.
Demonstrates proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point.
Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
Demonstrates ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner.
Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
Schedule : This is a night position. Monday - Friday 4:00 am – 12:30 pm. Work hours may be subject to change.
Accountabilities
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.
Qualifications
Bachelor’s degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred
2+ years of experience in related science field preferred
1-2 years of experience in Quality Assurance and/or regulated environment highly preferred – cGMP
Pharmaceutical or medical device experience a plus
Effective written and verbal English communication skills
ISO experience a plus
Ability to lift between 25 - 50lbs
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 actions to resolve
Applies judgment within defined parameters
Receives general guidance may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy
Ability to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions
Ability to exercise sound judgment Personal Protective Equipment
Anticipated salary range: $66,500 - $95,000
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: 6/9/2024 *if interested in opportunity, please submit application as soon as possible.
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.
To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)