Analyst II, Quality Control Microbiology

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Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

The Analyst II, Quality Control Microbiology performs routine GMP testing including environmental monitoring, utilities (water, gas), as well as other activities to support product manufacturing. This may include compendial testing, data analysis, data review, deviation investigations, gowning qualification, and other activities in support of the Quality Control Microbiology lab.

This is a site based role in Alachua, FL.

Position Responsibilities:

• Working in QC GLP and/or cGMP BSL-2, microbiology laboratory facilities and operations.

• Perform environmental and utilities monitoring.

• Perform QC release and in-process testing on raw materials and production samples.

• Participate in other activities such as deviation investigations, phase 1 laboratory investigations and out of specification investigations, etc.

• Supplies inventory and support of laboratory organization and routine cleaning.

• Perform testing of sampled raw materials, utilities and media.

Minimum Qualifications:

• Previous experience working in a GMP (QC) laboratory environment.

• Experience with the use of environmental monitoring equipment.

• Capable of working independently with minimal supervision.

Preferred Qualifications:

• Bachelor's degree in Microbiology, Biological Sciences, Biotechnology or related field.

• Relevant life science quality control experience.

• Experience working with bacteria, environmental monitoring, and utilities monitoring.

• Experience in basic Microbiology (ID, bioburden, endotoxin, and sterility)

• Experience with QC Microbiology data systems such as LIMS and MODA.

• Demonstrate the ability to understand and interpret test results and use the results to make a decision with regard to acceptance of the associated criteria and requirements.

• Strong oral and written communication skills for communicating with colleagues, management, other departments.

• Ability to work in a lab environment including wearing appropriate safety attire.

• Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.

• Ability to adhere and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.

This position may also include the following conditions:

• This role is primarily an active role which can include exerting up to 20 pounds of force to move objects.

• Visual acuity such as: reading test plates, working with data, viewing a computer terminal, extensive reading, operating equipment, general observations of facilities, etc.

• Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing)

• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators [PAPR], gowning, gloves, face protection, other barrier equipment, etc.)

• Handling, managing, disposing hazardous and non-hazardous waste.

• Packaging, transporting, and shipping of infectious or potentially infectious substances.

• Assist with the training of environmental monitoring personnel.

• Provide support for Manufacturing Operations by providing equipment, training, and/or monitoring of classified manufacturing areas.

• Other duties as assigned.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.