QC Microbiology Lead

Overview

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

Under the direction of the Microbiology and Sterility Assurance Manager, the QC Microbiology Lead is responsible for the day-to-day operations of the QC Microbiology Laboratory. The Lead will plan, direct and supervise the administrative activities of the QC Micro Lab. The Lead is responsible for evaluating material and product quality by performing various procedures in the Microbiology Laboratory and manufacturing facility.

The QC Microbiology Lead role must possess the skills to interact with formulation, filling, validation, engineering, and packaging personnel in support of those functions. The qualified candidate will work with and guide the efforts of Microbiology Laboratory personnel to assure test results, procedures, and methods are written. The lead must have the ability to execute testing in a timely manner.

The candidate must have the ability to work with a sense of urgency, assist with maintenance and analysis of Microbiological data, and work with other plant personnel to resolve problems related to actual or potential product quality problems. The Microbiology lead must have 5-6+ years of hands on pharmaceutical laboratory experience, and have the ability to work independently with minimal supervision.

• Leads and executes protocols (including environmental monitoring studies and equipment/method validations). Performs biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components.
• Laboratory assays included particulate testing, growth promotion of media, sterility testing, raw material testing, bioburden, membrane filtration, plate reading, endotoxin testing and environmental monitoring. Works in a team environment to support internal and external customer microbiology testing services.
• Identifies technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation process to resolve and correct. Performs studies to support the validation of test methods and ongoing validation studies as needed. Ability to teach and perform gown qualifications for all personnel in the facility.
• Implements on-going studies to document the scientific suitability of test methodologies fundamental to conformance and assessment. Ability to carry out method development/validation work with minimal guidance.
• Accountable for the accuracy and validity of testing results. Analyzes trends microbiology data on a monthly basis to identify potential concerns with product quality and correct deviant situations. Performs mathematical calculations, interprets results, and records observations.
• Ability to keep accurate records and performs monthly trend analysis for microbiology data to identify potential concerns with product quality and correct deviant situations. May utilize Laboratory Information Management Systems. Develops problem solving skills. Compiles data and generates reports in support of investigations, APQRs, KPI’s, QMRs, and validations.
• Trains all analysts in new and existing procedures, techniques and governmental regulations as directed by Manager. Mentors analysts by providing technical knowledge and support in resolving technical problems and reviewing documents.
• Maintains all…