The Microbiologist I is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, media growth promotion, maintenance of microbial cultures, 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 inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order. Responsibilities:
- Responsible for performing all microbiological testing of raw materials, utilities, and in-process and finished products.
- Responsible for performing all microbiological tests associated with methods development and validation.
- Responsible for performing daily, weekly, semi-weekly, and monthly 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, 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 Manager immediately of out of specification (OOS) results.
- Responsible for routine maintenance and preventative maintenance of laboratory equipment.
- Notify Microbiology Laboratory Manager 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 Manager.
- 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.
- Assist in regulatory audits as requested by the Microbiology Laboratory Manager.
- Responsible for performing all microbiological tests associated with product stability studies and cleaning validations that have been previously developed.
- 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 Manager, responsible for assisting in review of SOPs.
- Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.
- BS degree in Microbiology or related field with 0 - 2 years experience in a QC laboratory environment.
- Ability to understand/follow all applicable standard operating procedures and cGMPs/cGLPs 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 QC and between other departments.