Microbiologist

Summary

The QC Chemist –Microbiologist is responsible for all microbiological testing, validation, data generation, and documentation.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Performs all required microbiological testing utilizing analytical instrumentation and/or plates per internal methods.

· Maintains necessary laboratory notebooks and documentation per QSP 16.01.01 and MWI-195.

· Works safely with test strains of microorganisms in a Biological Safety Cabinet per established protocols.

· Revises existing and authors new Quality Operating Procedures for microbiological testing and operation of the microbiology lab.

· Authors and executes validation protocols for validation of an alternative microbiological method for USP<61> and USP <62> testing following the guidelines set forth in USP<1223>, Validation of Alternative Microbiological Methods.

· Authors and executes suitability protocols for each product line to be tested.

· Generates and reports all data to form validation reports.

· Verifies Incoming Microbiological Media

· Performs testing on incoming plates, broth, reagents, etc. to ensure they are suitable for use prior to releasing for Quality Control testing activities.

· Maintains inventory of all supplies needed for microbiological testing and communicates to Manager when supplies should be ordered.

· Sends out all samples to outside analytical laboratories that require additional testing.

· Maintains relationships and communication with outside laboratories.

· Updates Supervisor / Manager / Production with any issues or delays.

· Prepares products for final release following completion of microbiological testing.

· Gathers all required documentation and verifies it has been completed accurately prior to submittal for review.

· Enters data into internal data management system.

· Communicates with Shipping / Production concerning status of finished products.

· Manages the Environmental Monitoring Program for the entire site including the following activities:

· Obtaining test samples for microbiological assays.

· Managing environmental temperature and humidity data for the various recording locations.

· Recording all data per the appropriate procedures.

· Assisting in the investigation of any excursions.

· Assists in QC Lab testing of bulk / finished products / stability samples as needed.

· Maintains a neat and orderly working environment.

· Completes all training according to QC Microbiologist job function on the Training Matrix (GF-221) in accordance with QSP 18.01.01.

· Performs testing only after training on the applicable procedures required by the test has been completed and properly documented.

· Notifies QC Manager/Supervisor of all out of specification results according to Out of Specification(OOS) QSP 14.03.

· Performs other tasks, as assigned.

Competencies

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

Bachelors of Science in Chemistry, or Biology with sufficient Chemistry course work. Two plus years of experience in a microbiology lab is preferred.

Language Skills

Able to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

Mathematical Skills

Ability to calculate figures and amounts such as proportions, percentages, area, circumference and volume. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability

Ability to carry out instructions furnished in written, verbal, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and depth perception.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

While performing the duties of this job, the employee will be working in a laboratory environment with the use of microbiological test strains within a biological safety cabinet. In addition, the employee will work in an environment with hazardous chemicals and occasionally airborne particles. The employee will be required to wear the appropriate personal protective equipment including lab coats, particle respirators, chemical goggles/glasses, gloves, sleeves, etc. The noise level in the work environment is usually moderate, but in some cases can be high and require hearing protection.

Pay Range

The Microbiologist is a non-exempt position that is paid hourly. Pay rate will be dependent on a number of factors including but not limited to knowledge, skills, and experience.

EEO Statement

Dental Technologies Inc. is proud to be an equal opportunity employer.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.