Microbiologist I/Environmental Monitoring Specialist, RCM

Company: SOFIE
Location: Totowa
Posted on: April 9, 2025

Job Description:

Title Microbiologist I/Environmental Monitoring Specialist, RCM

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Location NJ5-Totowa, New Jersey

Department Radiopharmaceutical Contract Manufacturing

Overview: The Microbiologist I is responsible for managing Environmental Monitoring supports manufacturing activities at the NJ5. Main responsibility includes performing environmental monitoring, QC/microbiological testing, supporting investigations and process validations as per SOP and GMP guidelines.

Essential Duties and Responsibilities:

--- Assist in the oversight of the site environmental monitoring (EM) program including maintaining sampling schedules in accordance with procedures, performing sampling of rooms, equipment, and personnel, and performing EM sample management from incubation through isolate ID and completion of EM documentation per procedures and in LIMS.

--- Perform investigations, aid in determination of root cause and collaboratively determine required corrective actions for EM excursions, also evaluating EM results, review all microbiological trends (EM, cleaning, etc.) that may indicate declining microbiological control of the GMP production environment.

--- Support finished product release by performing microbiological and QC testing on finished product, raw materials, and stability and clinical samples. Document testing data per good documentation practices (GDP) and entering all results into LIMS.

--- Conduct training for new hires on aseptic gowning, EM testing, etc. as required or as instructed.

--- Aid in overseeing the inventory of EM materials and other materials required for microbiological media.

--- Support in creating and revising departmental SOPs and test methods.

--- Ensure compliance to all applicable standard operating procedures and regulatory guidelines.

--- Responsible for maintaining the safety and quality for the QC department.

--- Liaise with internal and external inspectors and representatives, as a site Microbiology SME and communicate effectively.

--- Ensure all QC equipment, incubators, and facilities are always maintained in a compliant manner.

--- Conduct review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.).

--- Maintain gowning validation and other qualifications as necessary to enter Grade C / ISO 7 production areas and Grade A /ISO 5 enclosures for the purpose of performing EM and evaluating aseptic practices.

--- Support continuous improvement of activities of microbiological processes by bringing innovative ideas and opportunities.

--- Support other responsibilities as required.

--- Communicate effectively internally and cross functionally, maintain respect for colleges, problem solving skills, multi-tasking, time-management, and organizational skills.

Qualifications:

--- Associate degree with 2-3 Years or bachelor's degree in a Life Science discipline (B.Sc. in microbiology or biology preferred) with 1-3 years in a cGMP laboratory/ production environment including performing environmental monitoring.

--- Knowledge of USP, FDA, and cGMP regulations preferred.

--- Ability to read, analyze, and interpret governmental regulations, professional journals, or technical procedures required.

--- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.

--- Ability to investigate and solve problems, collect data, establish facts, and draw valid conclusions required.

--- Proficiency in MS Office applications required.

--- Strong interpersonal communication skills to interact with site personnel, inspectors, and internal and external vendors required.

--- Knowledge in Lean Six Sig Sigma process improvement.

Keywords: SOFIE, Danbury , Microbiologist I/Environmental Monitoring Specialist, RCM, Other , Totowa, Connecticut