Senior Microbiologist
3 weeks ago
Senior Microbiologist:
ESSENTIAL DUTIES
• Prepares special solutions and reagents.
• Receives and prepares samples for microbiological testing.
• Keeps inventory and catalog laboratory samples, raw materials, general supplies, and reagents for the microbiological area.
• Responsible for specialized equipment maintenance, calibration, and cleaning.
• Tests raw materials and finished product samples using different equipment(s).
• Required to use different microbiological equipment such as Soleris, Air sampler, Analytical Balance, and other equipment, etc.
• Verifies tests results for raw materials and finished products.
• Writing and updating SOPs, and STMs used in the microbiological area of the QC lab.
• Conduct the Environmental microbiological testing of the different areas in the company.
GENERAL DESCRIPTION (Describe this job assuming it is for someone who has never done it.)
• Plan, execute and reports testing results using in-house microbiological and analytical instrumentation. Ensures in-house laboratory microbiological testing capacity and capability meets production timelines.
• Keeps inventory and catalog laboratory samples, raw materials, general supplies, and reagents in the microbiology area.
• Provides accurate evaluation and interpretation of microbiological data in compliance with FDA, EPA, OSHA and company regulations and policies as needed.
• Assists in routine analysis of samples submitted to the laboratory for microbial testing as part of customer product requirements.
• Maintains QC lab microbiological equipment in a validated state.
• Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS).
• Performs routine microbiological equipment maintenance, calibration and supervises third party maintenance and repair when necessary.
• Establishes good working relation with contract laboratories that conduct microbiological testing.
• Supports in the development and review of method transfers, validation, troubleshooting, IQ/OQ/PQ protocols, and reports that involve microbiological testing.
• Supports activities regarding contract lab audits in support of suppliers and of vendor certification program.
• Train QC staff in microbiological and facility testing as needed.
• Assist or perform facility sampling and testing as needed.
• Ensures control of preventive maintenance of lab equipment (IQ/OQ/PQ).
• “Other duties as assigned”
WORK EXPERIENCE AND SKILLS REQUIREMENTS
• Three or more years in related field.
• Exceptional knowledge of general microbiological equipment such as Soleris instrumentation and other equipment used in conventional microbiological analyses.
• Good understanding of cGMP.
• Excellent knowledge of Windows, Word, and Excel.
• Able to effectively communicate in English written and oral.
• Good analytical and observation skills.
• Good knowledge of basic mathematical skills, including measurement.
• Able to multi-task.
• Able to follow routine verbal and/or written instructions.
• Able to work under pressure and meet deadlines.
• The person will act in a safe manner and will ensure they are knowledgeable about safety SOP’s and the requirements for the position to ensure a safe working environment. All precautions and processes must be adhered to in order to maintain a high level of safety compliance.
EDUCATION REQUIREMENTS
• Bachelor’s degree in science, preferably in Biology or Microbiology.
SUPERVISION
Supervisor Job Title: QC Lab Manager
Department: Quality Control
• This job receives close supervision from the QC Supervisor.
• Other supervision is provided by the Director of Quality.
WORKING CONDITIONS
• This job is to be performed indoors in an office space (Laboratory).
Describe any hazards encountered on this job (hear, rain, radiation, fire, noise, heights, etc.).
• There are some hazards encountered in this job such as exposure to chemicals, raw materials, and lab equipment.
• This job requires the use of Personal Protective Equipment such as gloves, safety goggles, and lab coat.
• Possible exposure to raw material ingredients used in the processing of pharmaceutical and nutritional supplements and fluids used to clean equipment and facilities.
