Microbiologist

The Microbiologist I is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. The Microbiologist I 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 and ordering inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order.

• Please note that the shift for this position will be from 7PM-5AM.**

Level 1

• Less than 12 months experience or no experience
• Environmental Monitoring Completion
• Utilities completion
• Microbial Identification (subculture, Gram-stain, ID entry, VITEK MS assist) and enumeration
• Raw Material Testing including APIs

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 for performing daily, weekly, semi-weekly, and monthly environmental monitoring of the manufacturing environment and other areas.
• Responsible for performing enumeration, 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 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). Document and review of raw and final data to ensure complete and proper documentation according per procedures and applicable cGMPs.
• Responsible for maintaining and entering microbiological data (including Identification) into the Quality database and ensuring all data has been entered by review.
• 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 temperature monitoring, maintenance, and notification of calibration of laboratory equipment.
• Assist in regulatory audits as requested by Microbiology Laboratory Management.
• Assist in training of new employees on all applicable SOPs and tasks.
• Responsible for assisting with ordering and maintaining inventory of laboratory supplies including organization, labeling, and discard of materials.
• With guidance from Microbiology Laboratory management, assist in review of SOPs.
• Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.

Qualifications

• B.S. degree in Microbiology or related field.
• Minimum 0 – 1 year experience.
• Ability to understand/follow all applicable standard operating procedures and cGMPs routinely.
• 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 quality organization and between other departments.