Pharmacy Environmental Microbiology Analyst FT Days

Employer
AdventHealth Orlando
Location
Orlando, Florida, US
Salary
Competitive
Posted
Jun 09, 2021
Closes
Jun 16, 2021
Ref
2238198653
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Description
YOU ARE REQUIRED TO SUBMIT A RESUME WITH YOUR APPLICATION! Pharmacy Environmental Microbiology Analyst - AdventHealth - Orlando Central Fill Pharmacy Location Address: 3071 N Orange Blossom Trail Orlando, FL 32804 Work Hours/Shift: Full Time Days (8:30am-5:00pm) M-F
You Will Be Responsible For:

Demonstrates, through behavior, AdventHealth Orlando's service standards.
General Duties, Testing and Visual Inspections
  • Manages and performs the pre-analytical testing of samples including: incubation and enumeration of environmental and personnel monitoring samples and the visual inspection of personnel testing/media fill samples and testing controls
  • Performs other assigned pre-analytical activities related to laboratory testing, which may include general and analytical equipment maintenance, function checks and documentation; inventory control and supply stocking; viable sample collection; environmental sample processing; cleaning and disinfection of selected or assigned sample inspection equipment and spaces; quality control and calibration performance; and other pre-analytical activities.
Assessments, Investigations and Test Design
  • Conducts risk-based assessments, environmental plan qualifications, and provides rationale for appropriate sampling locations (development site-selection rationale)
  • Conducts microbiological investigations and provides consult as Pharmaceutical Microbiologist for contamination root cause and recommended remediation
Analysis, Trending, Reporting of Results
  • Prepares trending reports and performs microbial trend analysis of results received from Microbiology lab (and/or external contract laboratories)
  • Evaluates environmental monitoring plans and maps regularly with trending data to ensure that relevant data is being captured and plans are complaint with regulations as they are updated
Other Duties
  • Performs other duties as assigned or directed to ensure the smooth operation of the department or work area.
  • Provides support during regulatory inspections with duties such as document retrieval
  • Adheres to the AdventHealth Corporate Compliance Plan and to all rules and regulations of all applicable local, state, and federal agencies and accrediting bodies.
Qualifications

What You Will Need:
Required:
  • Bachelor's degree in Life Sciences is required. A degree focused in Microbiology is preferred or solid knowledge and experience of pharmaceutical microbiology
  • Minimum 3-5 years of experience in pharmaceutical or environmental microbiology
  • Minimum of 3 years of experience with aseptic technique, cleanroom operations, or microbial control
  • Knowledge of Pharmaceutical Microbiology as it relates to aseptic processing environments such as sterile compounding cleanrooms or sterile pharmaceutical manufacturing facilities
  • Personal qualities and interpersonal communication skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances
  • Critical thinker with perceptual and analytical approach to problem solving
  • Working knowledge of Microsoft Office applications of Word, Excel, PowerPoint, Outlook, and Internet knowledge skills
Preferred:
  • Mature judgment and the ability to handle confidential information within AdventHealth guidelines and applicable regulations.
  • Experience performing Environmental Monitoring for ISO classified environments
  • Experience leading and conducting environmental microbial investigations, disinfectant efficacy studies, and method validations
  • Experience conducting microbial identification of environmental samples
  • GMP/GLP experience preferred with regard to peer review of laboratory results
  • Understanding of cleanroom environments and mechanisms of primary and secondary engineering controls
  • Experience analyzing cleanroom pressure, temp and humidity as it relates to viable and non-viable results
  • Experience defending testing processes and procedures and results to regulatory inspectors
Job Summary:
The Pharmacy Environmental Microbiology Specialist works under the general supervision of the Quality Assurance Manager to perform pre and post analytical tests, trend and analyze environmental samples collected from pharmacy cleanrooms, sterile compounding environment, and personnel monitoring. The Pharmacy Environmental Microbiology Analyst will work closely with internal and external laboratories to peer review and interpret analytical results and prepare final reports. Provides expertise on risk-based site-selection rationale of sampling locations and conducts investigations providing root cause specific remediation advisement for microbial excursions. As a member of the of AdventHealth Orlando Pharmacy team, this specialist will actively contribute to the assuring quality of sterile compounding environments and safe sterile compounding. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

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