The Microbiologist III is responsible for performing all the microbiological testing related to finished product testing (including endotoxin testing and particulate testing), raw materials, utilities, and in-process testing, stability testing, and execution of test method validation when requested. Additional duties include performing environmental monitoring, microbial enumeration, microbial identification, media growth promotion, maintenance of microbial cultures, and sampling of utilities. Other responsibilities include maintenance and calibration of equipment, laboratory investigations as requested by management, inventory controls, validation assistance, and assisting with the operation of the laboratory as requested by Microbiology Laboratory Management. Level 1 - Environmental Monitoring Completion - Utilities completion - Microbial Identification - Raw Material Testing including APIs - Particulate Testing - Endotoxin Testing - Sterility Testing - Identification - Review Level 2 - Environmental Monitoring Completion - Utilities completion - Microbial Identification - Raw Material Testing including APIs - Particulate Testing - Endotoxin Testing - Sterility Testing - Identification - Review - Special Projects

Responsibilities:

• Responsible for performing all microbiological testing of raw materials, utilities, and in-process and finished products including endotoxin and particulate testing.

• Responsible for performing all microbiological tests associated with validation projects, product stability studies and cleaning validations.

• Responsible for performing all microbiological tests associated with methods development and validation.

• Responsible for performing environmental monitoring of the manufacturing environment and other areas.

• Responsible for performing growth promotion and purity tests on all microbiological media to be used for testing.

• Responsible for reading plates and enumeration of organisms.

• Responsible for performing organism identification including culturing, isolating, and maintaining of organisms.

• Document raw and final data to ensure complete and proper documentation according to TRC’s procedures and applicable cGMPs.

• Notify Microbiology Laboratory Manager immediately of out of specification (OOS) results.

• Responsible for routine maintenance and preventative maintenance of laboratory equipment. Also, responsible for verification that all equipment calibration is current and acceptable.

• Notify Microbiology Laboratory Manager of laboratory equipment problems.

• Responsible for reviewing and entering microbiological data into finished product batch records and other applicable laboratory documents (i.e. laboratory notebooks).

• Responsible for assisting with investigations for environmental monitoring excursions (action/alert level investigations), incidents/deviations, and OOS results as requested by the Microbiology Laboratory Manager.

• Responsible for coordinating documents ready for off-site storage to include documents located in the file cabinets.

• Responsible for the general maintenance and cleaning of the Microbiology Laboratory (including Identification and warehouse areas) including good housekeeping and a safe working environment.

• Responsible for maintaining and entering microbiological data into the Quality database and ensuring data has been reviewed.

• Responsible for monitoring, troubleshooting, maintenance, and calibration of laboratory equipment.

• Assist in special projects and regulatory audits as requested by the Microbiology Laboratory Manager.

• Assist in training of new employees on all applicable SOPs and tasks.

• Responsible for assisting with ordering and maintaining inventory of laboratory supplies.

• With guidance from Microbiology Laboratory Management, responsible for assisting writing SOPs,

• With supervision from the Microbiology Lab Management responsible for final reviewing and disposition of microbiological data and batch records.

• Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.

Qualifications

• BS degree in Microbiology or related field with a minimum of 3 years’ experience in a pharmaceutical QC laboratory environment (or equivalent).

• Proficient with current word processing, spreadsheets, and database software.

• Demonstrated knowledge of standard laboratory techniques and procedures as evidenced by prior work experience or on the job training.

• Ability to communicate technical and non-technical information in a clear and organized fashion both verbally and in writing.

• Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within QC and between other departments.