Responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of drug candidates. This role will provide on-going support to evaluate and enhance the site’s compliance to procedures and practices in accordance with current regulatory requirements and industry guidance. This position will report to the Associate Director for QA Microbiology.
• Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
• Engage directly with site personnel to promote low bioburden operations culture and to provide microbiological subject matter expert knowledge.
• Provide microbiological support to the internal audit and inspection readiness programs.
• Provide support for tracking and implementation of corrective and preventative actions related to microbiology and low bioburden operations.
• The candidate must be familiar with implementation of microbiological environmental monitoring programs and must understand interpretation of microbiological data including evaluation of trends.
• Support the review and approval of microbial control related documents, including but not limited to, SOPs, validation and qualification documentation, study protocols, risk assessments and deviation/investigations.
• Communicate updates, metrics and outstanding items to senior personnel when necessary.
• Provide assurance of consistency of IOPS Microbial programs and initiatives across multiple sites.
• Perform additional tasks as directed by senior management.
Skills, Qualifications & Experience:
• Requires BS degree in Life Sciences or related field and at least 8 years of relevant experience, preferably in the pharmaceutical or biotechnology industries.
• Experience should also include quality control microbiology, critical utilities and involvement with supporting regulatory inspections.
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