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

• Key Duties (ES):

• 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 Standard Operating Procedures (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.

• Supervisory Duties: N/A
• Core Competencies/Behaviors:

• Familiarity with microbiological testing is desired. Good communication skills, being detail-oriented, and being able to work well with others are necessary qualities.
• 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.
• Internal: Frequent contact with Manufacturing, Facilities, QA, and Receiving personnel. Frequent contact with management.
• External: Contact with technical service representatives and vendors may be required.
• 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.

• Compliance Requirements (ES): The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

• Physical Requirements (ES): Sits at a desk or bench 20% of the time and operates a personal computer using sign and finger dexterity. Collects samples in the manufacturing area or performs testing at the laboratory bench 70% of the time. 10% of the time, lifting, carrying, pushing, pulling chemicals, samples, and supplies weighing no more than 30 lbs.

• Physical Location of Role: Boca Raton, FL

• Education Requirements: B.S. in Biological Science or related science discipline.
• Experience Requirements: This position requires 0-3 years of experience in a laboratory setting.
• Preferred Experience: Work in a regulated environment (FDA, EPA, etc.) preferred.