Who are we?

This position requires knowledge, experience and skills to manage the microbiological group for a quality control operation, focusing on release of product and environmental monitoring and utility testing and corresponding lab investigations. Assessing, improving and maintaining local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, etc) are integral responsibilities of this position. Supervise resources and assets that could include a small team and multiple simultaneous projects. The position requires demonstrated application of standard principles, theories and techniques to solve specific problems in a productive manner and the ability to manage multiple projects.

• Ensure that all work is conducted according to GMP requirements.

• Ensure compliance with applicable regulatory guidelines and internal standards through gap assessments and remediation.

• Manage the method validation processes for the introduction of R&D materials.

• Approve technical documents.

• Resolve issues by focusing on root cause determination and implementing effective preventive actions.

• Represent the Microbiology Lab during regulatory and internal audits and applies technical expertise in response to related observations.

• Responsible for leading a team of degreed professionals in the day-to-day microbiological testing of raw materials, finished product and stability samples for pharmaceutical use

• Responsible for staying current with published industry guidelines such as ICH, USP Pharmacopeia, and FDA guidance documents

• Adapts departmental plans and priorities to address operational challenges within the QC Laboratory

• Establish requirements and execution plans for transfer and/or validation of methodology from R&D

• Manages quality metrics and KPIs, identifies areas of improvement, and leads implementation plans to achieve departmental goals

• Review and approve technical documents such as laboratory investigations, method validation protocol and reports, and purified water and environmental monitoring trend reports

• May function as an advisor to the site in terms of projects and operations where microbiological expertise is needed to make critical business decisions

• Establishes individual goals for team members that foster growth and development in line with site objectives and career aspirations

Qualifications

• 5+ years of experience working in a pharmaceutical environment

• 1+ years of experience in a managerial/supervisory role

• Master's degree or PhD in Biology, Microbiology or related field of study

Function

Sub Function

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