Microbiologist - Columbia Heights

Location: Columbia Heights, Minnesota
Posted On: 9/12/2017
Job Code: Microbiologist - Col
Job Description
Position Responsibilities:
This is largely a tactical role where the individual will serve as the voice of quality to the micro-biology, sterilization and parts cleaning teams to ensure stable production and rapid resolution of issues when they arise.
• Assure all Quality requirements are in compliance with regulations and product specifications
• Provide technical leadership and support to Operations and Sterilization Services personnel, including review and disposition of product non-conformances and out-of-tolerance conditions.
• Partner with Microbiology team to update Sterilization Services technical procedures, MFG processes/work instructions, validation protocols/reports, and CEA compliance documents
• Apply knowledge to the optimization of the sterilization process for multiple product lines and projects
• Provide production support for the clean room, sterilization and parts cleaning areas
• Provide new product development sterilization / microbiology validation support
• Review and approve all areas of sterilization validation (EtO, radiation, and steam)
• Work with little guidance to help design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
• Work with little guidance to help develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within organization.
• Lead the analysis of issue trends and escalation process as necessary to maintain compliance to internal CAPA procedures.
• Use Continuous Improvement methodologies to improve quality and first time yield while reducing non-value added activities and cost
• Support internal and external audits, and assist with written responses to FDA for IDE’s, PMA’s and PMA supplements.
• Review engineering change orders.
• Be a team member to resolve non conformances and implement corrective action
• Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement/corrective activities.
• Participate or lead special projects as assigned.

Basic Qualifications:
• Bachelors Degree
• 5+ years experience as a Microbiologist with medical device operations experience.
• Expertise in the following areas:
• Sterilization standards, compliance documents, endotoxin testing (including standards compliance), microbiology lab testing (including bioburden and sterility testing), EtO residual testing and requirements, CEA compliance and certification.
• Parts Cleaning experience
• Project Management.
• Good written and verbal communication skills.
Category:IT  code:new
Job Requirements
Engineering, ISO 9001, Compliance, Management, MS Access, Project Management

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Contact Details
Chirag Sharma
E-mail Address