Microbiologist I at The Ritedose Corporation
Posted in Science 8 days ago.
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Location: Columbia, South Carolina
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.
- 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.