Job Description

Job Location: The Ritedose Corporation - Columbia, SC 29203
Position Type: 2CEducation
Level: 4 Year Degree
Salary Range: $28.69 - $30.89 Hourly

Job Shift: Day
Job Category: ScienceThe Microbiologist II 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 inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order.
**The schedule for this position will be from 5:00PM - 3:30AM.**
Level 1
-    Environmental Monitoring Completion
-    Utilities completion
-    Microbial Identification, enumeration, subculture, Gram-stain, ID entry, VITEK MS
-    Raw Material Testing including APIs
-    Review
-    Growth Promotion
Level 2
-    Minimum 2 years of Pharmaceutical EM and Microbiology laboratory
-    Endotoxin Testing
-    Particulate Testing
-    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.
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Qualifications
- 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.