Job Description

Job Purpose:

Microbiology Investigation Assistant Manager manages and ensures compliance with FDA regulations in areas of non-conformance investigations, memorandums, deviations, and corrective and preventive actions (CAPAs) for the Microbiology department. Creates and executes investigation and project work plans and revises, as appropriate, to meet changing needs and requirements. Identifies resources needed and assigns individuals responsibilities. Manages day-to-day operational aspects of the investigation process.

Essential Duties and Responsibilities:

• Manages and provides support for the completion of CAPAs, Quality Events (QEs), excursions, memorandums, and deviations as they pertain to the Microbiology department.
• Bridges the gap between Microbiology and other departments.
• Works closely with R&D and QC management to ensure coordinated investigations and/or projects are assigned and communicated between all of microbiology.
• Reviews reports, training, and data for impacted departments to ensure all training related to investigations are completed.
• Establishes a timeline for each phase of investigations, as well as a completion date for the entire project.
• Ensures investigation documentation is complete and current.
• Microbiology Standard Operating Procedure (SOP) review, revision and creation
• Ensures all Microbiology investigations are completed in a thorough, expeditious manner to meet the needs of the company.
• Works collaboratively with the Quality Investigations Team, if needed, with attention to any repeated occurrences of similar root causes.
• Communicates all Microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the Assistant Director of Microbiology, VP of Operational Excellence, or designee.

Supplemental Functions:

• Performs other duties as assigned.

Requirements

Job Specifications and Qualifications:

Knowledge & Skills:

• Ability to organize, coordinate, and review investigations for the Microbiology department.
• Written and oral communication skills.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• The ability to take strategic objectives and accept accountability, motivate and influence others, thinks globally and leverages diversity.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to create new products and processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.
• Specific expertise, skills and knowledge within training and special projects gained through education and experience.
• A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.

Education/Experience:

• Bachelor’s degree preferred with 2-3 years of pharmaceutical experience in quality systems preferred.
• 1-3 years of experience with MS Word, Excel, PowerPoint.
• 1-2 years management and investigation coordination experience.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.