Senior Specialist, Quality Assurance

Cardinal Health•Fort Lauderdale, FL

19h•$68,500 - $88,020•Onsite

About The Position

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. 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.

Requirements

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
Ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner, a plus
Understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving, a plus
Ability to travel 50%-75%.

Nice To Haves

Pharmaceutical or medical device experience a plus
ISO experience a plus
Understanding of the requirements and can perform gap assessments to those requirements, a plus
Ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner, a plus
Understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving, a plus

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.