Microbiologist II - Review & Investigations

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The Microbiologist II is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. The Microbiologist II is also responsible for performing all the microbiological testing related to raw materials, utilities, and in-process product testing. Other responsibilities include data entry, data review, ensuring calibration of equipment, maintaining inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order.

Level 1

• Environmental Monitoring Completion
• Utilities completion
• Microbial Identification, enumeration, subculture, Gram-stain, ID entry, VITEK MS
• Raw Material Testing including APIs
• Review
  • Documentation, logbooks, batch records, reports, investigations, etc.
  • Media fills
  • Product Release
  • Task Tracking
• Growth Promotion
• Endotoxin Testing
• Particulate Testing
• Sterility set-up

Level 2

• Minimum 2 years of Pharmaceutical EM and Microbiology laboratory
• Assist with Special Projects

Responsibilities:

• Responsible for performing all microbiological testing of raw materials, utilities, and in-process, and final products/stability (as applicable) for commercial and method development.
• Responsible (as applicable) for assisting with special projects.
• Responsible for performing daily, weekly, semi-weekly, and monthly environmental monitoring of the manufacturing environment and other areas.
• Responsible for reading plates and enumeration of organisms.
• Responsible for performing organism identification including culturing, isolating, entry, and maintaining of organisms.
• Document and review of raw and final data to ensure complete and proper documentation according to TRC's procedures and applicable cGMPs.
• Notify Microbiology Laboratory management immediately of out of specification (OOS) results.
• Responsible for routine maintenance and preventative maintenance of laboratory equipment.
• Notify Microbiology Laboratory management of laboratory equipment problems or calibration issues.
• 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), deviations, and OOS results as requested by the Microbiology Laboratory management.

• 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 (including Identification) into the Quality database and ensuring all data has been entered by review.
• Responsible for temperature monitoring, maintenance, and notification of calibration of laboratory equipment with some troubleshooting.
• Assist in regulatory audits as requested by the Microbiology Laboratory Manager.
• Assist in training of new employees on all applicable SOPs and tasks.
• Responsible for performing the necessary preparation and testing needed for the maintenance of TRC's Microbial Culture Collection (HMCC).
• Responsible for assisting with ordering and maintaining inventory of laboratory supplies.
• With guidance from Microbiology Laboratory management, responsible for assisting in review of SOPs.
• Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.

• BS degree in Microbiology or related field with 1 year of pharmaceutical QC Microbiology laboratory experience 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 operate standard and advanced laboratory instrumentation as evidenced by prior work experience or on the job training.
• Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within QC and between other departments.