Job Description

Microbiologist II reports to and takes direction from Microbiology Management. This individual works closely with

Management on department strategy and work projects.

Essential Duties & Responsibilities:

• Performs environmental monitoring of controlled manufacturing areas.
• Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles.
• Incubates viable samples.
• Streaks and sends representative EM isolates to contract laboratory for identification. Receives results and performs data entry for trend analysis.
• Complies with annual gowning qualification.
• Performs sanitation and temperature verification of laboratory refrigerators and incubators.
• Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purifies water (PW), and clean steam (CS) systems.
• Submits samples for testing to microbiology laboratory or contracted laboratory for TOC, conductivity microbial count, and endotoxins.
• Performs routine monitoring of gases for viable particles, non-viable particles, oil, and moisture.
• Performs bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples.
• Performs gram stain and growth promotion tests.
• Performs tests for bioburden and microbial limit.
• Performs visual inspection of microbiological, EM samples and media fill units.
• Performs data entry of results in Excel for trend analysis.
• Reviews microbiology laboratory data.
• Generates OOS or Out of EM Action/Alert Levels Notification, when required.
• Lead laboratory investigations and/or support manufacturing investigations, when required.
• Generate Change Controls for Equipment/Instruments qualifications, Process or Document Changes.
• Lead procedures, methods or specifications revisions acting as Contributor using Master Control System.
• Other tasks as requested by management.

Requirements

Position Requirements and Qualifications:

Education:

• BS or MS in a scientific discipline or equivalent and a minimum 2-4 years related experience.

• Expert knowledge of scientific principles and concepts.

Special Skills:

• Other special projects and/or duties may be assigned by Management.

• Trains other Microbiologist on Department methods, process and procedure.

• Works with other departments to accomplish Company goals or projects.

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions,

and procedure manuals.

• Ability to write routine reports and/or correspondence.

• Ability to speak effectively before groups or employees of organization.

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Work Environment & Physical Demands:

General work environment and physical demands as required to successfully perform the essential functions of this

job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may

be involved.

Supervisory Responsibility, if any No

This position description is not a complete list of all responsibilities, duties or skill required for the job and

is subject to review and change at any time, with or without notice, in accordance with the needs of the

organization.