Senior Specialist, Quality Assurance
Compensation
The Role
*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.
*Job Summary*
The Senior Specialist, Quality Assurance role will support, Nuclear Manufacturing. This is part of a growing Technical Operations team within Cardinal Health’s 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.
*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 Regional Quality Manager (RQM) and others as necessary. This includes timely escalation of discrepancies upon identification.
- 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.
- Works cross-functionally and can interpret the requirements as well as educate and influence others on those requirements.
*Schedule*
- Onsite in Fort Lauderdale, FL. 40 hours per week. Typically, Monday – Friday between the hours of 1:45 am and 12:30 pm depending upon client demand.
- Candidate must be available to work weekends to provide coverage at site as needed. Weekend work will be limited.
- 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.
This position is based on-site at a PET manufacturing facility. 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.
*Qualifications*
- Bachelor's degree in related field, or equivalent work experience, preferred
- 2+ years of experience in related science field preferred
- 1-2 years of experience in Quality Assurance and/or regulated environment preferred; cGMP, highly preferred.
- Pharmaceutical or medical device experience a plus
- ISO experience a plus
- Effective written and verbal English communication skills
- 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.
- Knowledge of quality systems and approaches
- Proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point.
- Understanding of the requirements and can perform gap assessments to those requirements, a plus
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Benefits
Estimated- Competitive pay
- Health insurance
- Paid time off
- Growth opportunities