This listing was posted on Professional Diversity Network.
Microbiologist, Sterility Assurance
Location:
Somerset, NJ
Description:
Job Description | Microbiologist, Sterility AssuranceTitle | Microbiologist, Sterility AssuranceLocation | Somerset, NJDepartment | Quality/Regulatory/EH&SReports To | Director, Sterility AssuranceOverviewThe Microbiologist, Sterility Assurance supports manufacturing activities for the SOFIE network by (1) detecting, quantifying, identifying and investigating possible contaminants that may impact the quality of product during different stages of the manufacturing process, (2) establishing and monitoring the state of microbiological control at SOFIE sites via quarterly environmental monitoring trend reports and other measures, (3) assessing aseptic behavior and practices of SOFIE personnel and assessing the effectiveness of cleaning and sanitization programs, (4) writing, reviewing, and training staff on sterility assurance related procedures, protocols, and exception documents, and (5) performing necessary validations and qualifications to support sterility assurance initiatives.Essential Duties and Responsibilities Assist in overseeing SOFIE's environmental monitoring (EM) program including developing procedures, reviewing sampling of rooms, equipment and personnel, and monitoring EM sample management from incubation through isolate ID and completion of EM trend documentation. 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. Reviewing SOFIE network quarterly EM trending reports. Preparing protocols for necessary sterility assurance validations and qualifications and executing them. Assisting operations, purchasing, and QA with the necessary assessment of sterility assurance related materials, such as gowning or media, and providing the necessary assessments and documentation to support the materials use. Assist in overseeing the inventory of EM materials and other materials required for media fills and finished product testing at SOFIE network 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 and site-specific procedures relative to their job functions. Write, review, approve, and implement procedures, specifications, processes, protocols, and methods as required. Liaise with internal and external inspectors and representatives, as a Microbiology expert. Work under and cooperatively with the corporate Director, Sterility Assurance to develop, evaluate and maintain SOFIE Sterility Assurance initiatives. Also, participate in network Microbiology/Sterility Assurance initiatives and investigations. Develop and deliver training related to microbiology and sterility assurance to SOFIE personnel. Help ensure all microbiology testing equipment, incubators and facilities are maintained in a compliant manner at all times. 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, when necessary, to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations. Ensure compliance to 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 participating in media fills, as applicable) to enter ISO 7 production areas and ISO 5 enclosures for the purpose of performing EM and evaluating aseptic practices. Identify opportunities to bring subcontracted microbiological testing in-house. Work closely with site Quality Assurance Specialist(s) and corporate QA to ensure facilities is operating in an environmental state of control. Perform facility walkthroughs for moisture, mold, etc. when needed. Performs fogging and/or cleaning of classified and non-classified areas, when necessary. Other responsibilities as required.PDN-9b72629c-93c5-48c5-83ed-ccfbb0299272
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to Professional Diversity Network
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Microbiologist, Sterility Assurance
Microbiologist, Sterility Assurance is a Science, Pharmaceutical & Biotech Jobs Microbiologist Job at Monster located in Somerset NJ. Find other listings like Microbiologist, Sterility Assurance by searching Oodle for Science, Pharmaceutical & Biotech Jobs Microbiologist Jobs.
Microbiologist, Sterility Assurance is a Science, Pharmaceutical & Biotech Jobs Microbiologist Job at Monster located in Somerset NJ. Find other listings like Microbiologist, Sterility Assurance by searching Oodle for Science, Pharmaceutical & Biotech Jobs Microbiologist Jobs.