The Company is currently seeking a dynamic individual to fill our Microbiologist position. You must be able to perform routine microbiological quality control testing of pharmaceutical products and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations. Assist in special testing studies of experimental, investigative, validation studies and problem solving nature. Participates in programs to achieve departmental objectives; records and reports results; notes unusual results and notifies supervision for evaluation. This position requires a continuation of training and learning to become proficient with routine testing procedures, compendial methods, cGMP, and associated SOPs.
Details of the job include:
Performs routine microbiological testing of raw material, in-process, finished product and stability following approved specifications, and Standard Operating Procedures (SOPs). This may include but is not limited to antibiotic testing, bioburden/microbial limit testing, antimicrobial effectiveness testing, water testing, environmental monitoring, microbial isolation and identification technique, sterility, and endotoxin testing.
Completes testing with a high degree of efficiency, reliability, and accuracy.
Maintains the Microbiology Laboratory. This may include but is not limited to maintenance, calibration, and use of standard laboratory equipment.
Logs samples received into the laboratory and assess their integrity upon receival.
Performs assigned work in timely and safe manner conforming to regulatory, company and compendial requirements.
Records and reports test data correctly, completely and accurately within company and departmental policies and guidelines. Notifies supervision of unusual results for evaluation.
Actively assumes and demonstrates responsibility in learning practical laboratory skills, and a thorough knowledge of microbiological theories, methodologies and procedures.
Acquires complete knowledge and understanding of company and departmental policies pertaining to cGMP, cGLP, safety, health, security, and departmental operation. Complies with company and departmental regulations, policies and guidelines in performance of the job.
Recognizes problems within scope of job and promptly and clearly communicates them to supervision. Follows directions and demonstrates proper judgment when a deviation occurs.
Initiates Laboratory Investigations (LIR) and Notices of Events (NOE). Reviews OOS and unusual test/equipment data with management or senior staff. Completes LIR or NOE under the direction of management and advisement of more experienced laboratory staff.
Recognizes trends, deviations, problems and promptly reports them to laboratory management. Follows directions and demonstrates proper judgment when a deviation occurs.
Participates in inventory control. Maintains a neat and orderly workspace, adhering to all laboratory disinfection policies.
Assist in performing experiments related to problem solving for the Microbiology department, under the direction of more experienced analysts and/or laboratory management.
Trains less experienced employees on new methods or procedures in the lab, under the direction of laboratory management.
Assists in microbial method validation, coordinates the materials required for method, process and system validations as under the direction of more experienced analysts and/or laboratory management.
Bachelors Degree in Microbiology or related science field and 2 to 4 years related experience; or an equivalent combination of education and experience/training.
Knowledge Necessary To Perform Job:
Thorough knowledge of all basic concepts of Microbiology and awareness of the importance of aseptic technique in performing testing.
The ability to effectively communicate to other departments and management status of testing and special projects.
Knowledge Desired To Perform Job:
Knowledge of FDA, ISO, OSHA and DEA regulations. .
Knowledge of laboratory safety procedures for safely working with a wide range of microorganism