Microbiologist Technician

Summary

The Microbiologist Technician is responsible for monitoring, controlling, and preventing microbial contamination throughout the manufacturing process in support of maintaining product quality and safety. This associate ensures that products meet the stringent requirements of Good Manufacturing Practices (GMPs) among other applicable standards and is a part of the Quality Control Department.

 Key Duties and Responsibilities

• May perform routine microbiological testing on raw materials, in-process and finished products using compendial methods such as USP, AOAC, FDA-BAM and in-house validated methods.
• May perform retesting of out-of-specification (OOS) results, assists with OOS investigations and OOS reports as directed.
• May perform water sampling at various ports and performs bioburden, TOC and conductivity testing.
• May perform Environmental Monitoring (EM) testing (for air and surface) per established test method and or approved test protocol(s).
• May review water and EM test results and may assist with investigation of excursions and preparation of relevant reports as directed.
• May communicate testing progress or project status to Microbiology Lab Supervisor/designee.
• Performs timely cleaning and disinfection and handling biohazard and general waste.
• Operates, maintains and ensures calibration of equipment including thermometers, analytical balances, pipettes and other related equipment used in the Microbiology lab.
• May assist with new equipment qualification/validation projects.
• Complies with cGMP, cGLP, FDA, and other applicable industry regulations.
• Obtains samples from production and process samples for testing, including media preparation as directed or outlined in respective test protocol(s).
• May conduct specific microbiological assays under the guidance of the Microbiology Lab Supervisor/designee.
• Processes samples from receipt through testing, including all associated documentation and recordkeeping including data entry, helping to ensure that all steps are completed in a thorough and timely manner.
• Adhere to and models good manufacturing practices (GMP) and good laboratory practices (GLP) at all times.
• May participate in internal cGMP and regulatory compliance audits as necessary.
• Maintain a clean and organized work area.
• Maintain a positive and productive relationship with co-workers and others with whom the position may have contact.
• Perform other duties as assigned.
• Based on company needs, overtime is required.

Requirements

To fulfill the requirements of the 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

• BA/BS degree in Microbiology, Chemistry, Biology, Biochemistry or related field.
• Good computer skills with knowledge of Microsoft Word, Access and Excel.
• Effective oral and written business communication skills
• Ability to multi-task, work effectively and complete projects in a fast-paced environment.
• Ability to read and interpret documents such as material safety data sheets, safety rules, operating and maintenance instructions, and procedure manuals and test methods. Ability to speak effectively with employees, peers, and management within the organization.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent, and calculate dilution factors.

Physical Requirements

The physical requirements 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, reach with hands and arms, use hands to finger, handle or feel objects, tools or controls; talk and hear.  The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl.  The employee must occasionally lift and/or move up to 25 pounds.  The employee is required to view computer monitors and stand for extended periods of time.

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 is occasionally exposed to moving mechanical parts and fumes, airborne particles, and pathogenic organisms.  The noise level in the work environment is usually moderate.

The pay rate range for this role is $19.00 – $24.00 per hour.  Compensation is commensurate with level of knowledge, education, skills, and experience applicable to the position.

We understand that each team member’s situation is unique, and so it is our intent to offer an overall benefits package that can be shaped and molded by each individual to fit their family’s needs. Our current benefits package, which is available to all full-time team members, includes medical, dental, vision insurance, 401k retirement plan, flexible spending accounts, life and disability coverage, and other voluntary benefits.

We want everyone to feel welcome, respected and we are committed to providing the best space, experience and workplace for our teams – no matter what race, color, religion, sex, sexual orientation, gender identify, national origin, veteran or disability status and all the other fascinating characteristics that make us different.

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