Sterility Assurance Officer

6 days ago

Dallas, United States SOFIE Full time

Job Description | Sterility Assurance Officer



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

Location | Onsite Department | Quality / Compliance

Reports To | Director, Sterility Assurance



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.

  • Quality Assurance Officer

    1 month ago

    dallas, United States TSR Consulting Services, Inc. Full time

    Our client, a leading financial services company, is hiring a Quality Assurance Officer on a contract basis. Job ID#: 80522 Work Location: Dallas, TX or Jacksonville, FLSummary: The Quality Assurance Officer is a strategic professional who stays abreast of developments within own field and contributes to directional strategy by considering their application...

  • Quality Assurance Officer

    1 month ago

    dallas, United States TSR Consulting Services, Inc. Full time

    Our client, a leading financial services company, is hiring a Quality Assurance Officer on a contract basis. Job ID#: 80522 Work Location: Dallas, TX or Jacksonville, FLSummary: The Quality Assurance Officer is a strategic professional who stays abreast of developments within own field and contributes to directional strategy by considering their application...

  • Quality Assurance Officer

    1 month ago

    Dallas, United States TSR Consulting Services, Inc. Full time

    Our client, a leading financial services company, is hiring a Quality Assurance Officer on a contract basis. Job ID#: 80522 Work Location: Dallas, TX or Jacksonville, FLSummary: The Quality Assurance Officer is a strategic professional who stays abreast of developments within own field and contributes to directional strategy by considering their application...

  • Quality Assurance Supervisor

    4 weeks ago

    Dallas, United States Del Monte Fresh Produce Company NA, Inc. Full time

    Purpose of Position:This position will be responsible for assisting the Quality Assurance Manager in the supervision of Food Safety and Security, and Quality Assurance programs. In this role, will also oversee the direct supervision of Quality & Sanitation Technicians to ensure all Quality, Food Safety and Sanitation guidelines are implemented and adhered...

  • Quality Assurance Supervisor

    4 weeks ago

    Dallas, United States Del Monte Fresh Produce Company NA, Inc. Full time

    Purpose of Position:This position will be responsible for assisting the Quality Assurance Manager in the supervision of Food Safety and Security, and Quality Assurance programs. In this role, will also oversee the direct supervision of Quality & Sanitation Technicians to ensure all Quality, Food Safety and Sanitation guidelines are implemented and adhered...

  • Quality Assurance Nurse

    2 weeks ago

    Dallas, United States AmTrust Financial Services, Inc. Full time

    Overview Seeking a dynamic, innovative, collaborative professional who embraces commitment to superior service and quality. AmTrust Financial Services, an industry-leading insurance provider and top writer of workers' compensation insurance, has a need for a Quality Assurance Specialist in medical case management oversight for workers' compensation within...

  • Quality Assurance Team Leader

    4 weeks ago

    Dallas, United States Fresh Del Monte Full time

    Purpose of Position:This position will be responsible for assisting the Quality Assurance Manager in the supervision of Food Safety and Security, and Quality Assurance programs. In this role, will also oversee the direct supervision of Quality & Sanitation Technicians to ensure all Quality, Food Safety and Sanitation guidelines are implemented and adhered...

  • Quality Assurance Team Leader

    4 weeks ago

    dallas, United States Fresh Del Monte Full time

    Purpose of Position:This position will be responsible for assisting the Quality Assurance Manager in the supervision of Food Safety and Security, and Quality Assurance programs. In this role, will also oversee the direct supervision of Quality & Sanitation Technicians to ensure all Quality, Food Safety and Sanitation guidelines are implemented and adhered...

  • Assurance Manager

    4 days ago

    Dallas, United States EisnerAmper Full time

    Job Description At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact. Whether you're starting out in your career or taking your next step as a seasoned professional, the EisnerAmper experience is one-of-a-kind. You can design a career you'll love from top to bottom - we give you the tools you...

  • Quality Assurance Manager

    3 hours ago

    Dallas, Texas, United States Turner Construction Company Full time

    Job DescriptionThis is a salaried exempt position. Estimated salary: $80,000-$120,000 per year.About the JobWe are seeking an experienced Quality Assurance Manager to lead our QA/QC team in delivering high-quality projects. As a key member of our project team, you will be responsible for planning, coordinating, and developing project-specific quality...

  • Corporate Quality Assurance Specialist

    6 months ago

    Dallas, United States Daisy Brand Full time

    The Corporate Quality Assurance Specialist is responsible for fostering a culture of quality excellence. This role is focused on driving continuous improvement of product quality and processes. In addition, this individual will support the Quality Department and Corporate Food Safety & Quality Manager in other project activities as needed. ...

  • Assurance Manager

    4 weeks ago

    Dallas, United States CohnReznick LLP Full time

    As CohnReznick grows, so do our career opportunities. As one of the nation’s top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do! We currently have an exciting career opportunity for an Assurance Manager to join the Financial...

  • Quality Assurance Manager

    1 month ago

    Dallas, Texas, United States Turner Construction Company Full time

    Job Title: QA/QC ManagerTurner Construction Company is seeking a highly skilled QA/QC Manager to join our team.Job Summary:The QA/QC Manager will be responsible for planning, coordinating, and developing project-specific Quality Assurance/Quality Control (QA/QC) plans that incorporate policies and procedures necessary to deliver projects fully compliant with...

  • Quality Assurance Team Leader

    3 weeks ago

    Dallas, TX, United States Fresh Del Monte Full time

    Purpose of Position:This position will be responsible for assisting the Quality Assurance Manager in the supervision of Food Safety and Security, and Quality Assurance programs. In this role, will also oversee the direct supervision of Quality & Sanitation Technicians to ensure all Quality, Food Safety and Sanitation guidelines are implemented and adhered...

  • Assurance Manager

    1 week ago

    Dallas, United States CohnReznick LLP Full time

    Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. As CohnReznick grows, so do our career opportunities. As one of the nation’s top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and...

  • Assurance Manager

    5 days ago

    dallas, United States CohnReznick LLP Full time

    As CohnReznick grows, so do our career opportunities. As one of the nation’s top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do! We currently have an exciting career opportunity for an Assurance Manager to join the Financial...

  • Assurance Manager

    2 weeks ago

    dallas, United States CohnReznick LLP Full time

    As CohnReznick grows, so do our career opportunities. As one of the nation’s top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do! We currently have an exciting career opportunity for an Assurance Manager to join the Financial...

  • Assurance Manager

    1 week ago

    Dallas, United States CohnReznick LLP Full time

    Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. As CohnReznick grows, so do our career opportunities. As one of the nation’s top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and...

  • Pharmacy Technician I

    6 days ago

    Dallas, United States SOFIE Full time

    Overview Do you have the skills to fill this role Read the complete details below, and make your application today. The Pharmacy Technician will perform laboratory and pharmacy related duties under the direct supervision of an authorized Nuclear Pharmacist. This job involves working in a clean room as well as occupational exposure to radiation. Essential...

  • Food Safety and Quality Assurance Technician

    1 month ago

    DALLAS, United States Sysco Full time

    JOB SUMMARYMonitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIESMonitoring of FSQA programs including HACCP Program, sanitation standard operating...