The QC Lead Associate, Data Review 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 analytical methods and supporting data management processes. Analytical disciplines requiring data review common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity.

_{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 CAPA's, audit actions, deviations, lab investigations, method revisions, and other related Quality System activities}
• _{Creates certificates of analysis and stability reports}
• _{Identifies and notifies management and initiates events (such as deviations) in the quality systems to solve problems.}
• _{Prioritizes and organizes work to deliver assignment according to established schedules and deadlines. May coordinate logistics associated with laboratory testing or supporting documentation with others in group.}
• _{Capable of meeting schedule RFT, high quality effort, taking initiative to communicate, coordinate, and adjust work efforts to achieve these objectives.}
• _{Proactively identifies and implements improvements with minimal oversight}
• _{Applies lean, six sigma and other process improvement methodologies that contribute to solutions of technical issues}

_{BACKGROUND REQUIREMENTS:}

_{Minimum Education Requirements}

• _{BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field}

_{Desired Experience}

• _{8+ years related laboratory experience (4 years required with relevant MS degree)}

_{Specific Skills and Competencies}

• _{Proficiency in Empower or Softmax Pro, as well as MS Office. Familiarity with data management processes such as Trackwise or LIMS or capability to learn basic use and navigation within the systems.}
• _{Has developed basic technique skills and is capable of working 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}
• _{Capable of identifying and escalating problems to superiors}
• _{Ability to manage changing priorities in a productive and positive manner}
• _{Can communicate effectively with colleagues in department, building trust and respect}
• _{Problem solving and troubleshooting competencies}
• _{Able to make informed and timely decisions independently}

_{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. 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.}