Bright Innovation Labs

Job Title: Microbiologist
Department: Quality Control
Reports To: Senior Quality Manager
FLSA Status: Non-exempt
SAFETY is the single most important part of any position at Bright Innovation Labs and Employees will:

Follow and adhere all safety rules and regulations.
Report ALL injuries immediately to manager or supervisor
Report unsafe acts, conditions and work practices to manager
Whenever appropriate, use safety tools and protective equipment as required.
Maintain equipment in good condition with all safety guards in place.
Encourage co-workers and other employees to be mindful or working safely at all times.

Failure to follow safety rules may result in disciplinary action up to and including termination.
To control and assure and provide technical support for production by means of basic microbiological analyses of finished products, in-process bulk samples, raw materials, and water. To sample and test raw materials, water and environmental air for microbial contamination. Maintain quality standards by adhering and upholding programs to safeguard product safety and quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Comply with Bright Innovation labs’ policies, SOP’s, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations.
Perform microbiological testing of raw materials, finished products, in-process bulk samples and water samples, using Bright’s approved methods.
Understand and perform testing with RMM (Rapid Microbiological Methods)
Investigate Out-of-Specifications (OOS) and perform root cause analyses.
Ensure accuracy of results and documentation prior to releasing products for distribution.
Interface with QC, Production, Compounding and R&D as needed.
Prepare media, reagents and standards per manufacturer’s directions. Prepare, maintain and use microbial cultures for inoculation as directed.
Understand and perform Gram stain and identification of contaminants through the use of API Kits and /or send samples to the outside lab for identifications as directed.
Write and /or execute validation protocols as directed.
Follow GDP (Good Documentation Practices) to document analytical results, utilizing approved forms and reports and assigned Logbooks. Interface with QC & QA Managers in reporting inconsistencies or discrepancy of test results.
Perform above mentioned duties independently.
Maintain instruments, calibration of gauges, and document equipment performance as directed.
Promote compliance with Bright Innovation Labs’ policies, procedures, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations. Participate, as required, in safety and GMP training sessions, and other company training sessions.
Bachelor’s degree in Microbiology, Biology, or other life or physical science. Entry level to minimum of 3 years working experience commercial or industrial laboratory. Experience in a production or process development environment in the consumer products or drug industry preferred. Experience in performing Suitability and Challenge testing.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to use Microsoft Word, Excel and Outlook
Ability to use laboratory equipment such as a microscope, incubators, autoclaves, hot plates, laboratory glassware, pipettes, etc.
Ability to perform work with minimal supervision and guidance
Ability to multi-task
Accurate and have strong attention to detail
Flexibility with schedule including shift work
Overtime may be required with very little notice
Must successfully pass a background check and drug screen

Must have strong verbal and writing skills along with strong communication skills. Must be able to speak, read, and write in English. Ability to read, analyze, and interpret common scientific and technical manuals and instructions, professional journals, technical procedures, or governmental regulations. Ability to write basic reports, and assist in editing procedure manuals. Ability to effectively present information and respond to questions from laboratory staff and quality personnel.
Ability to apply mathematical concepts such as exponent, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deals with several abstract and concrete variables.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may occasionally experience exposure to wet and/or humid conditions, moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment in these situations may be low. Normal work environment has low levels and mild humidity.

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