Senior Quality Assurance Specialist

What Quality Assurance contributes to Cardinal Health

This Quality Assurance role will support, Nuclear Manufacturing position is part of a growing Technical Operations team within Cardinal Healths Nuclear and Precision Health Solutions organization tasked with the development and technology transfer of radiopharmaceutical products into and among our network of qualified manufacturing facilities.

• Tech Transfer projects are the leading priority for this Quality Assurance position.
• 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.

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 judgement 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.
• This position is based on-site at a PET manufacturing facility in Beltsville, MD. Based on specific needs in the network, about 50% - 75% travel time may be required to support projects requiring on-site technical transfer quality review at other PET manufacturing facilities.

Schedule: 40 hours per week. This is a night position. Typically Monday - Friday 1:30 am - 9:30 am and one Sunday per month 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.

Responsibilities

• Primary focus in the role is to deliver QA support for the review and approval on all operational documentation as it relates to the technical transfer project such as protocols, validation documents, etc. This role will be accountable to the technical transfer leadership team while executing tech transfer projects
• Travel to other PET manufacturing sites network-wide to provide quality review of technical transfer projects when required.
• When not supporting technical transfer projects, candidate will be responsible for all other quality functions at the PET manufacturing site, such as: 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

• Bachelors degree in related science field(Microbiology, Chemistry, Biology, Physics) preferred, or equivalent work experience
• 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

• Anticipated salary range: $74,500 - $101,100
• 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: 2/20/2024 *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.