The QAC Laboratory Senior Microbiologist is the process owner and subject matter expert for environmental systems and products to provide support for production, facility, engineering, and quality departments. They are responsible for staying current on applicable regulatory and industry standards and recommend improvements.
• Work cross-functionally with maintenance, facilities, operations and Quality Assurance and Control Laboratory.
• Review maintenance and controlled manufacturing and utility breaches and determines testing required.
• Perform gap assessments for external regulations and recommend improvements.
• Drive continuous improvement to sampling plans and environmental monitoring program.
• Support Controlled Manufacturing Area Room Qualifications.
• Develop and conduct cleaning validations.
• Independently solves problems of moderate scope.
• Generate protocols, reports, and procedures.
• Perform accurate and compliant data and record management.
• Mentor and train other Microbiologists and coworkers according to
procedures and regulations.
• Maintain training requirements.
• Maintain good documentation and laboratory practices.
• Must have excellent problem solving skills and attention to detail.
• Perform other duties as necessary.
• BA/BS or MA/MS Degree in Biology, Microbiology, or related field or experience of such kind and amount as to provide a comparable background.
• Advanced working knowledge and understanding of regulations (e.g. ISO 14644, ISO 13485, ISO 11737, AAMI ST72, etc.).
• Working knowledge of Microsoft Office (i.e. Excel, Word and Outlook).
• 10 years hands-on laboratory experience preferred.
• Must be able to perform reasonable job functions requiring periods of standing, walking, climbing, balancing, lifting up to 50lbs, as well as those requiring manual dexterity, effective listening and communication.
• Personal protective equipment including safety glasses, lab coat and gloves required in most areas associated with this position.