Essential Duties and Responsibilities

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Perform environmental monitoring (air, surface, compressed gas, and personnel) of the cleanrooms and laboratory to support GMP manufacturing to include off-hours/weekend coverage as needed.
• Assist in maintaining microbiology and QC laboratories in a clean, orderly, compliant, and inspection-ready condition.
• Execute laboratory experiments and assays (osmolality, pH, endotoxin, sterility, plate reading, etc.).
• Perform data review and calculation verifications.
• Participate in laboratory investigations including deviations and out of specifications.
• Assist with laboratory equipment maintenance and calibration as needed.
• Assist with environmental monitoring and assay related investigations.
• Assist with qualification and validation of equipment, processes, and analytical methods, including protocol development and execution.Gai
• Ensure all activities are performed in accordance with company policies, procedures, SOPs, GMP requirements, applicable regulatory expectations, and data integrity principles.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

Required:

• High school diploma and a minimum of 2 years related experience.
• Proficiency in Microsoft Office suite applications
• An equivalent combination of education and experience may be considered.
• Strong organizational, communication, and analytical skills.
• Able to prioritize and manage through multiple complex processes/projects.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Detail-oriented and highly motivated with excellent written and verbal communication skills.
• Ability to work independently and stay on task in a fast-paced environment without direct supervision.
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
• Able to wear cleanroom/protective gowning and equipment, including but not limited to full body gowning, goggles, face shields, and protective gloves for extended periods of time.

Preferred:

• Bachelor’s degree in microbiology, biology, or another relevant scientific discipline.
• Experience working within a cleanroom is a plus.

Schedule

• Monday through Friday
• 2^nd shift
• Occasional Weekends and Overtime Required
• Training will take place on 1^st shift

Travel Requirements

• None

Location

• This is a laboratory-based position located at the Gainesville, FL site.

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