University of Florida - Alachua, FL

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This position is located in Alachua, Florida (not on UF campus in Gainesville) at the Center of Excellence for Regenerative Health Biotechnology (Florida Biologix) in Alachua, FL.

This is a temporary, OPS position. This incumbent assists in the day to day operation of the audit and inspection function in the Quality Assurance Department of the Center of Excellence for Regenerative Health Biotechnology’s biopharmaceutical contract manufacturing facility (Florida Biologix) in Alachua, FL. The position works individually and with other members of the QA Department for the timely completion of controlled production and test record audits, environmental monitoring data review, label inspection and room clearance, raw material release documentation, and assisting with the internal inspection procedures in Florida Biologix. In addition, the position assists with the improvement of quality compliance by recognizing continuing issues and bringing them to QA management’s attention; makes recommendations to operating departments on procedural or documentation related improvements; assists with maintenance of quality systems related to compliance, including but not limited to, deviations, quality investigations, environmental monitoring trending, and quality control activities; and supports and maintains the systems used to track audits, inspections, responses to audits, corrective actions, preventive actions, etc. The position reports to the Quality Assurance Director.

Work hours:
Monday through Friday; 8:00 am to 5 pm
Mandatory overtime in evening and on weekends and holidays, when needed to meet project timelines. Must be flexible in regards to work schedule.

Minimum Requirements:
A high school diploma and four years of appropriate experience. Appropriate college coursework or vocational/technical training may substitute at an equivalent rate for the required experience.

Health Assessment Required

Preferred Qualifications:
Bachelor’s degree in biology, microbiology, chemistry, biotechnology with two years of appropriate work experience or a two-year degree in science and four years of appropriate experience.

One year of work experience in a quality assurance department in a biopharmaceutical company.

Incumbent must have excellent organizational and communication skills. Capacity to write and follow standard operating procedures. The ability to read, write, understand and be understood in English is mandatory.

Strong computer skills including Microsoft Word, Excel, and Access.

Special instructions to applicants:

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