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.

The QC Lead Associate, Data Reviewer position is a position that supports a broad range of analytical disciplines within the Quality Control laboratory. The individual performs data review for testing of high throughput, right-first-time laboratory work to meet production schedules, and project milestones, and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of microbiological methods and supporting data management processes. Microbiological disciplines requiring data review common to the laboratory include, but are not limited to, Bioburden, Kinetic Chromogenic Endotoxin, Culture Purity, Environmental Monitoring, and Microbial Identifications.

This is a 1st shift position with a schedule of Sunday to Wednesday.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Responsible for data review for a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills, disciplines, and procedures within assigned discipline area(s)
• Support the data review for CAPAs, audit actions, deviations, lab investigations, method revisions, and other related Quality System activities
• Embrace lean lab and Six Sigma principles and apply them to laboratory processes
• Reviews technical data and provides an expert review and input to new methods and revisions. Creates summary reports and provides an expert interpretation of data
• 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
• May provide technical services (such as preparing reports and initiating deviations) from preexisting templates.
• Capable of meeting schedule RFT, high-quality effort, and taking initiative to communicate, coordinate, and adjust work efforts to achieve these objectives.
• Trainer within areas of proficiency
• Assists with deviations, lab investigations, procedure changes, and method transfer planning
• 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 informing and consulting with area management
• Conveys holistic view of data in the context of validity, reliability, and impact relative to the batch at hand and other related batches and processes.
• Proactively identifies and implements improvements with minimal oversight
• Manages multiple assignments of increasing complexity and responsibility
• Generate reports and recommendations based on statistical data, can identify statistically significant and impactful events
• Performs or leads laboratory investigations, identifies deviations, and implements corrective actions
• Applies process improvement methodologies that contribute to solutions to technical issues
• Can communicate in a manner that fosters cooperation and creates a safe environment for those involved

BACKGROUND REQUIREMENTS:

• BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or a related technical field
• 3-6 years of related laboratory experience 
• Possesses an understanding and knowledge of procedures and practices in assigned area
• Has developed basic technique skills and can work within established procedures
• Capable of working with a moderate degree of supervision and organizing own time
• Familiarity with basic statistical tools to analyze data in relation to trends results
• Familiarity with data management processes such as Trackwise or LIMS or the capability to learn basic use and navigation within the systems.
• Capable of identifying and escalating problems to superiors
• Can manage one or more tasks in a manner that promotes effective schedule adherence.
• Ability to manage changing priorities in a productive and positive manner
• Can communicate effectively with colleagues in the department, building trust and respect
• Ability to learn and incorporate lean lab and Six Sigma principles into the daily work environment.
• Able to achieve Yellow Belt Certification within the company’s Six Sigma program
• Technical writing skills (write basic protocols, prepare complex reports without a template)
• Problem-solving and troubleshooting competencies
• Able to make informed and timely decisions independently
• Ability to contribute beyond own product/department

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.