Senior Microbiologist, Technical Specialist

Werfen•Norcross, GA

9h•Onsite

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain, and is a worldwide leader in specialized diagnostics in areas like Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. They also have an Original Equipment Manufacturing (OEM) business line for customized assays and biomaterials. Werfen operates directly in 30 countries and over 100 territories through distributors, with Headquarters and Technology Centers in the US and Europe, and a workforce of more than 7,000. Their success stems from a focus on rapidly evolving diagnostic areas, commitment to customers, and dedication to innovation and quality, aiming to provide healthcare professionals with valuable solutions to improve hospital efficiency and patient care. The Senior Microbiologist, Technical Specialist is a senior leader within Biological Quality Assurance, a division of the Quality Laboratory. This role involves leading and analyzing BQA laboratory test results in a GMP environment, using scientific education and experience to generate results according to GMP/procedural requirements and scientific principles. The specialist works cross-functionally and with various organizational levels, both locally and globally, interpreting data to ensure conformance with microbial monitoring requirements and performing trend analyses. They review and verify data from others, drive continuous improvement, understand internal business processes for work prioritization, and are proficient in multiple laboratory techniques.

Requirements

Bachelor's Degree (BS) from four-year college or university; or equivalent combination of education and experience.
Minimum of 5 years of work experience in a medical device/biopharmaceutical production/quality organization.
Experience in microbial contamination control including in-depth knowledge of microbiological techniques, aseptic processing, and environmental monitoring.
Conducts themselves in a polite, helpful, and professional manner with all employees both inside and outside of the department.
Understands source, composition and characteristics of products and associated microbiological, chemical and biosafety hazards.
Interacts cooperatively with coworkers, supervisors or managers of other departments and receives direction well from superiors.
Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner.
Must be able to work within an evolving environment.
Must be able to accept and adapt to change in work schedule on a daily basis.

Nice To Haves

MSc preferred (in Microbiology)

Responsibilities

Leads and influences team members with their tasks and activities by providing on-the-floor support for both manufacturing and laboratory operations, ensuring adherence to safety rules, aseptic techniques and microbiological controls including troubleshooting and resolving microbiological issues in real-time to support uninterrupted production.
Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
Develop and implement strategies to drive performance while maintaining best-in-class aseptic techniques in QC Micro and Operations.
Track and trend microbiological performance data and collaborate with cross-functional teams to investigate and resolve microbiological issues and deviations to identify root causes, implementing corrective actions, and prevent recurrence through continuous improvement initiatives.
Assists with development and delivery of microbiology related training programs including aseptic operator training.
Leads and takes a proactive role in design, qualification/validation, and maintenance of critical aseptic technique related processes and studies.
Provides oversight of environmental monitoring program including design and maintenance of environmental monitoring, review of routine/process environmental monitoring, water system, and compressed air for trends and supports identification of appropriate corrective/preventive actions as required.
Assists in training, retraining, and competency assessment of employees.
Identifies contamination risks and drives improvements related to the reduction of contamination risks on the shop floor with close cooperation with operators and management of the Manufacturing and Facilities/Maintenance departments.
Understands FDA and ISO standards applicable to the department and consequences of nonconformance.
Support implementation of metrics and drive the performance of the metrics.
Participate in the SOP review and revision process.
Performs other duties and responsibilities as assigned by the Manager, Laboratory Services.