Microbiologist I, Quality Control

Role Summary

Perform environmental monitoring and water sampling within the controlled manufacturing areas and QC Laboratory.

Responsibilities

• Perform environmental monitoring within the controlled manufacturing areas and QC Microbiology Laboratory in accordance with approved Standard Operating Procedures (SOPs). Environmental sampling includes viable air, total airborne, surface, and settle plate test methods, as well as compressed gas sampling.
• Water sample collection is performed within the controlled manufacturing areas, utility areas, and QC Laboratory in accordance with approved SOPs.
• Must qualify on gowning to enter various manufacturing areas and be able to gown multiple times per day, as needed.
• Participate in the generation of alert and action-level excursion documentation as needed.
• Assist with generating data for environmental monitoring and water collection trending reports, as needed.
• Perform growth promotion testing on media.
• Participate in material and reagent receipt for the QC Microbiology Laboratory.
• Assist in the generation of work order requests.
• Assist in performing inventory as needed.
• Participate in daily and monthly meetings.
• Fulfill requests from management for assistance in other matters as needed.
• Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
• Utilize cGMP practices in the documentation and execution of job functions.
• Familiarity with microbiological testing is desired.
• Good communication skills, being detail-oriented, and the ability to work well with others.
• The individual should be flexible and able to handle multiple priorities. Able to use a personal computer for data entry.
• Perform math calculations involving dilutions, fractions, decimals, and percentages. Understand and follow instructions, record information, find solutions to practical problems, or request assistance.
• Exercises judgment within defined procedures to determine appropriate action for routine problems.
• Prioritization of work will be done with the direction of QC Management.
• Exposure to infectious material (human-source products), toxic chemicals, chemical fumes and odors, electrical hazards, and temperature extremes when going to and from coolers and freezers.
• Long or unusual work hours may be required for quality control testing during the manufacturing of immunotherapy products. This may also require occasional weekend or holiday work or early/late hours.

Qualifications

• Required: 0-3 years of experience in a laboratory setting.
• Preferred: Work in a regulated environment (FDA, EPA, etc.).

Skills

• Familiarity with microbiological testing is desired.
• Good communication skills; detail-oriented; able to work well with others.
• Flexible and able to handle multiple priorities; proficient with personal computer data entry.
• Perform math calculations involving dilutions, fractions, decimals, and percentages; ability to follow instructions, record information, and solve problems or request assistance.
• Exercises judgment within defined procedures to determine appropriate action for routine problems.

Education

• B.S. in Biological Science or related science discipline.

Additional Requirements

• Physical requirements: Sits at a desk or bench 20% of the time; operates a computer; collects samples in the manufacturing area or performs testing at the laboratory bench 70% of the time; 10% lifting, carrying, pushing, pulling chemicals, samples, and supplies weighing up to 30 lbs.
• Location: Boca Raton, FL