Microbiology Development Tech 3 | PayRate - $26/Hr

Job Description

Job Description

Title: Microbiology Development Technician III

Location: Sandy, UT 84070

Shift: 1st Shift North America, Monday – Friday, 40 hours a week.

Job Description:

Core Requirements:

• We need someone who has an understanding of micro lab testing/techniques that can get up and running quickly to perform compendial micro testing.
• Must be comfortable using Microsoft Suite tools.
• Typical Day: Micro testing assigned by area supervisor a week beforehand. Weekly tasks can include bioburden, endotoxin, BI, microbial limits or Environmental testing, plate reads, general test set up, and lab 5S cleanup.
• Priority Soft Skills: Micro testing and EM troubleshooting ability, high-speed manufacturing environment, cleanroom environment.
• Preferred Background: Prior micro lab experience preferred.

Job Summary: Supports the Quality Assurance Laboratory by performing a variety of tests as part of product release and the sterilization assurance program. As assigned, performs environment monitoring in classified GMP manufacturing areas, executes protocols in an EO sterilizer staging area, and tests for organisms in a lab or cleanroom setting. Supports these activities with appropriate documentation following GDP.

Job Responsibilities:

• Maintains the cleanliness and orderliness of laboratory glassware.
• Performs verification of lab equipment.
• Maintains and distributes chemicals and supplies.
• Maintains materials’ inventory.
• Conducts monthly inspections of laboratory safety equipment.
• Complies with regulations as outlined in GMPs.
• Disposes of laboratory waste.
• Aseptically and safely works with live organisms and cultures.
• Performs basic microbiological testing on raw materials and finished goods to ensure compliance to specifications.
• Works inside varying ISO classifications of cleanrooms, including those with active manufacturing, to perform testing.
• Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas chromatography (GC-FID).
• Conducts investigations in a timely manner.
• Writes technical reports.
• Writes and updates standard operating procedures and laboratory documents/forms.
• Work overtime as needed by the department. Work flexible hours as business needs require.
• Communicate in an effective, timely, and appropriate manner to all associates (i.e. peers, support teams and management) including escalating issues.
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous Waste regulations.
• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Other duties as assigned. (This is not intended to be an all-inclusive listing of duties. Other job-related duties may be required.)

Education and Experience Requirements: This position requires:

• Two years relevant experience working in a laboratory environment or equivalent experience.
• Experience with ISO and USP standards.
• Understanding of GLP, GMP, and GDP.

Preferred qualifications include:

• BS Degree in Microbiology/related STEM Degree.
• Knowledge of basic Microbiological or EO Sterilization terminology.
• Pharmaceutical and/or Medical Device experience.
• Experience in a manufacturing environment.
• Experience working with Bioburden BI’s, PCD’s, EO Residuals, Endotoxins and/or Environmental monitoring and other Microbial related testing.
• Experience with Labware, Empower and SAP.

Knowledge and Skills: Critical Knowledge and Skill to perform and deliver to the scope and deliverables of the job:

• Working knowledge of metric system.
• Ability to Interpret drawings and specifications.
• Effective written and oral communication skills (English), math skills, and interpersonal skills.
• Basic computer skills.

Work Environment & Physical Demands:

• This position is in a clean room or laboratory manufacturing environment and the physical demands described are representative of those that must be met by an incumbent to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990).
• The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequently required. While performing this job, the employee is regularly exposed to episodes of walking, kneeling, balancing, crouching, pushing/pulling, repetitive grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers.
• The position will have some exposure to work near moving mechanical equipment, and potential temperature fluctuations.
• Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
• The incumbent may be exposed to noise levels in the work environment moderate to loud.
• The incumbent must be willing and able to wear required PPE such as, safety glasses, face mask and/or shield, hearing protection, safety shoes, hair and beard net and smock.