Sterility Assurance Officer at SOFIE

Job Description | Sterility Assurance Officer 

Title | Sterility Assurance Officer (SAO) (Microbiologist/On the floor Quality) 

Location | Gilroy, CA and Dallas, TX.

Department | Quality / Compliance 

Reports To | Sterility Assurance Officer, Manager

Overview 

SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Sterility Assurance Director and provides Quality on the floor oversight to the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. Duties of the successful candidate will include, but are not limited to, (1) observing, and training aseptic operators, performing audits of aseptic practices including but not limited to aseptic manipulations in ISO 5 environments, general cleanroom behavior, gowning, and cleaning and instructing operators in real-time on appropriate behavior. (2) writing, reviewing, and approving environmental monitoring (EM) reports, investigating and addressing EM trends, and providing sterility assurance oversight to manufacturing operations. This person will play an active and integral part of the Quality team supporting compliance and improvement at all SOFIE facilities.  

Essential Duties and Responsibilities  

·         Provide quality assurance support and oversight (i.e., on the floor quality) to the SOFIE Network. This includes observing and training aseptic operators and instructing operators in real-time on appropriate behavior. This observation shall occur during manufacturing operations (i.e., overnight / early morning hours.) 

·         Perform audits of aseptic practices including but not limited to aseptic manipulations in ISO 5 environments, general cleanroom behavior, gowning, and cleaning.  

·         Be a quality liaison, develop solid relationships, and establish open communication with SOFIE network sites, specifically aseptic operators such as Pharmacists, Pharmacy Technicians, and Manufacturing operator.  

·         Assist in performing investigations, determining root cause, and providing expert guidance on required corrective actions for EM excursions, also evaluating EM results for trends that may indicate declining microbiological control of the GMP production environment at SOFIE facilities. 

·         Performing sterility failure and media fill failure investigations, if needed. Perform other sterility assurance and microbiology related investigations. 

·         Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network procedures relative to their job functions. 

·         Write, review, and implement procedures, specifications, processes, protocols, and methods as required. 

·         Work under and cooperatively with the corporate Director, Sterility Assurance to develop, evaluate and maintain SOFIE Sterility Assurance initiatives.  

·         Along with the QA Manager, Training, develop and deliver training related to microbiology and sterility assurance to SOFIE personnel. 

·         Support creation and review of EM trending reports. 

·         Review job relevant trends (e.g., environmental monitoring, cleaning, sanitization, etc.) to initiate corrective and preventive actions and/or for continuous process improvement. 

·         Conduct review of aseptic operations at SOFIE facilities to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations. 

·         Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 211, 212, and UPS requirements. 

·         Maintain training on current procedures, including gowning validation and other qualifications as necessary (including cleaning validation) to enter ISO 7 production areas and ISO 5 enclosures for the purpose of performing EM and evaluating aseptic practices. 

·         Perform root cause analysis and develop meaningful Corrective and Preventive (CAPA) actions to address exception events.  

·         Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve sterility assurance related issues.   

·         Continuously seek to improve sterility assurance. 

·         Be a Subject Matter Expert resource for the entire network for the key area: Aseptic Technique.  

·         Perform other tasks as required by the Director, Sterility Assurance. 

·         Domestic travel up to 50%.  

Qualifications  

·         Bachelor of Science Degree (B.Sc.) in an appropriate scientific subject (Microbiology or Biology preferred but will entertain applicants with relevant education and work experience).  

·         2+ years of work experience in Quality Assurance in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred.  

·         Experience writing technical reports preferred.  

·         Familiarity with radiopharmaceutical manufacturing processes and related QC release testing preferred.  

·         Working knowledge of CGMP regulations and guidelines, risk management standards, quality attributes, and Quality Assurance best practices in the pharmaceutical industry required.   

·         Experience working with customers and partners preferred.  

·         Excellent analytical, prioritization, multi-tasking, communication, and the ability to work independently with limited supervision required.  

·         Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required.  

·         Ability to prepare and present written and verbal reports to upper management required.  

·         Ability to project manage and have excellent organization and prioritization skills.