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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
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.
What You Will Need:
Bachelorâ™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
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
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.
At AdventHealth, Extending the Healing Ministry of Christ is our mission. It calls us to be His hands and feet in helping people feel whole. Our story is one of hope — one that strives to heal and restore the body, mind and spirit. Our more than 80,000 skilled and compassionate caregivers in hospitals, physician practices, outpatient clinics, urgent care centers, skilled nursing facilities, home health agencies and hospice centers are committed to providing individualized, wholistic care.