Lead QC Associate 2

Position Overview

The QC Microbiology Lead Associate 2 is a position that supports a broad range of microbiological disciplines and manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory. This is first shift ( Sunday- Wed 7am-5pm)    The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with little to no supervision. They are expected to follow procedures and have mastery of a variety of microbiological methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Microbiological disciplines common to the laboratory include but are not limited to aseptic technique, environmental and clean utility monitoring, bioburden and endotoxin determination, Gram staining, non-host (culture purity) testing, stock culture preparation and maintenance, cell culture maintenance, and associated viral titer assays. The position primarily works independently taking direction from their manager or senior department staff, meanwhile providing direction to junior analysts and peers within the department. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.Incumbents in this role will have primary assigned responsibility for Environmental Monitoring functions or Microbiology support, depending upon department needs and individual capacity.

Company Overview

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At FUJIFILM Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

Job Description

Required Skills/Education:

 

• BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences microbiology or biological sciences, or related technical field
• Has advanced technique skills and is capable of working beyond established procedures to identify and implement process improvements
• Familiarity with basic statistical tools to analyze data in relation to trend results
• Familiarity with data management processes such as Trackwise and LIMS or the capability to learn advanced functionalities within the systems
• Can manage one or more tasks in a manner that promotes effective schedule adherence
• Ability to identify and manage changing priorities in a productive and positive manner
• Can communicate effectively with colleagues in the department and cross-functionally, building trust and respect
• Able to achieve Yellow Belt Certification within the company’s Six Sigma program
• Technical writing skills (ability to write basic protocols, deviations, and prepare complex reports with or without a template)
• Problem-solving and troubleshooting competencies
• Able to make informed and timely decisions independently
• Ability to contribute beyond own product/department

 

Desired Skills:

 

• 6-8 years related laboratory experience (4 years required with relevant MS degree)
• Has complete understanding and knowledge of procedures and practices in assigned area
• Demonstrated SME and responsible for CAPAs, audit actions, deviations, lab investigations, method revisions, transfers, validations, and qualifications
• Support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution, and data review
• Embrace lean lab and Six Sigma principles and applies them to laboratory processes
• Notifies management and initiates events (such as deviations) in the quality systems
• Prioritizes and organizes work to deliver assignments according to established schedules and deadlines. 
• May coordinate logistics associated with laboratory testing or supporting documentation with others in the group
• Trainer within areas of proficiency
• May have some assigned project responsibilities, such as department representation, document development or review, troubleshooting, and protocol execution
• Contributes to the achievement of team goals and a sense of teamwork within the unit and across the department
• Identifies and solves problems while