Position Overview

Investigator 2, Manufacturing is responsible to perform investigation for Cell Culture, Fermentation and Downstream programs to identify impact for events/minor/major and close PRs within the required standard work timeframe. This role contributes to the creation of effective corrective
and preventative actions (CAPA's) while ensuring timely closure of assigned investigations.

Job Description

Major Accountabilities:

• Able to work on event, minor and major investigations with applying site and global compliance SOP's.
• Identify and address corrective and preventative actions (CAPAs) based on root cause analysis and ensure they are implemented and effective.
• Organize, participate in and/or lead cross-functional investigational teams including internal and external (client) members.
• Track and analyze performance metrics to identify trends and develop continuous improvement projects.
• Participate in Problem Analysis (PA) sessions.
• Support document revisions, review/ approval of investigation records and participate in quality improvement initiatives.
• Prepare storyboards for significant deviations and ability to present to regulatory agencies.
• Participate and/or lead difficult discussions to internal team, clients and regulatory agencies.
• Attend and participate in meetings, including tier meeting, internal and external client calls, team huddles, business review meetings, and others as needed.
• Supports junior investigators regarding investigative techniques and best practices.
• Demonstrated knowledge of cGDPs and cGMPs and the requirements to operate in a clinical and commercial manufacturing environment.
• Ability to independently prioritize work based on program needs and deviation timelines.

Minimum Requirements:

• High School Diploma or Equivalent with 9 years of applicable industry
  experience OR
• Associate's degree with 7 years of applicable industry experience OR
• Bachelor's degree with 5 years of applicable industry experience OR
• Master's degree 3 years of applicable industry experience
• Understanding of cGDPs and cGMPs and the requirements to operate in a clinical and commercial manufacturing environment.

Preferred Qualifications:

• Understanding of operational excellence and the ability to apply root cause analysis, problem solving and continuous improvement methodology.
• Strong knowledge of Excel, Word, and PowerPoint
• Root Cause Analysis (RCA) training

Knowledge, Skills, or Abilities:

• Knowledge of change management, investigations, CAPAs, and continuous improvement.
• Strong technical writing and facilitation skills.
• Ability to effectively lead cross-functional teams during analysis and CAPA discussions.
• Ability to identify appropriate casual analysis tool for assigned investigations.
• Team based attitude and ability to work in a global team environment and build relationships.
• Ability to effectively present information and findings to others.
• Effective communication, both written and oral.
• Knowledge of performance improvement with a basis in Human and Organizational Performance principles.
• Ability to analyze and extrapolate data, and synthesize and determine recommendations, including the analysis of complex problems.
• Ability to interpret and document technical information and records from multiple subject matter experts (SMEs) into a coherent, clear, and concise narrative to support the investigation process.

Physical Requirements:

• Ability to stand for prolonged periods of time (120 minutes)
• Ability to conduct activities using reptitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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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.