Microbiologist I

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).
• 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.