Job Description

Responsible for maintaining quality standards for client’s pharmaceutical and medical device products by leading and managing day-to-day activities for the Microbiology Team. This includes ownership of the Environmental Monitoring Program as well as any relevant in-house and outsourced testing. Provides QC microbiological guidance and support throughout all the project.
This position is onsite, reporting to the Sr. Director of Quality Control.
Principal Duties and Responsibilities include the following:

• Provide leadership in the QC Unit to ensure compliance, drive improvements and achieve schedule adherence in accordance with production timelines.
• Own and maintain the site’s Environmental Monitoring (EM) Program.
• Ensure all microbial testing is performed in a timely manner in support of manufacturing operations and batch disposition activities.
• Escalate EM excursions and work with cross-functional teams in their investigation and resolution.
• Perform trend analysis of environmental monitoring data and generate trend reports.
• Accomplishes department objectives and manage and develop staff.
• Retain staff by recruiting, selecting, and training employees according to internal practices and policies.
• Lead/manage deviations, change controls and CAPAs associated with QC Micro, as necessary.
• Review departmental documentation (e.g., Standard Operating Procedures, test data, deviation and CAPAs).
• Acts as the QC Micro SME in all projects being conducted at the site as well as during internal and external audits.
• Participate in risk assessments associated with contamination risks and own the Contamination Control Plan.
• Define a strategic plan and coordinate the transfer of outsourced testing to be conducted in-house.
• Adhere to all the policies and procedures as well as to the GxPs.
• Identify opportunities for improvement and implement necessary actions to enhance the processes.
• Participate in the implementation of new electronic systems, such as LIMS.
• Perform additional duties as deemed appropriate.

Qualifications:

• Bachelor’s or Master’s degree with 7-10 years of experience
• Validated experience in Quality Control Microbiology within a cGMP environment.
• Strong leadership skills with the ability to efficiently implement central initiatives.
• Excellent collaboration and communication skills.
• In-depth knowledge of microbiological methods, contamination control, and environmental monitoring programs.
• Experience handling QC laboratories and leading technical teams.
• Ability to resolve priorities, deploy resources effectively, and achieve outstanding results.

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