Microbiologist IIISUMMARY OF FUNCTIONS:
Responsible for operational aspects of Microbiology, Environmental Control and Sterilization.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manages the microbiological testing of products for sterility, bioburden, bacterial endotoxins, and environmental monitoring.
• Ensures quality system and Good Laboratories Practices (GLP) compliance and approves new and revised SOPs related to Microbiology, Environmental Control, and Sterilization. Responsible for ensuring that all appropriate training in relevant Orthovita quality system procedures, standards, FDA QSR, the European Medical Devices Directive, company policies and procedures, and Safety is conducted. Ensures that all employees under their direction meet the qualification requirements for the job to which they are assigned.
• Analyzes and interprets microbiological testing data. Establishes alert and action limits and prepares professional trend reports for management review. Recommends preventive and corrective actions regarding microbiological issues. Provides input for regulatory submissions pertaining to aseptic processing, sterilization validation, environmental monitoring, etc.
• Performs assigned internal, subcontractor, pre-clinical and human clinical site quality system audits in accordance with cGMP/QSR and ISO/EN requirements.
• Prepares budgets, evaluates new equipment and makes purchasing recommendations.
• Prepares and coordinates sterilization validation master plans, protocols, and validation reports.
Qualifications/Work Experience
Ability to read, analyze, and interpret complex documents.
Ability to respond effectively to sensitive inquiries or complaints.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.)
Proficient in Microsoft Office Suite skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, etc.
Education and/or Special Training
A Bachelors degree in Microbiology or Life Science from a four-year college or university; or five to seven years related experience and/or training: or equivalent combination of education and experience.
Percent Travel Required
10
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