Investigator II

Job Description

About This Role

The Investigator II is responsible for maximizing organizational learning and improvement from Quality deviations occurring in manufacturing operations.Assigned investigations include cross site deviationsof both low and high risk. In some situations, the Investigator II will facilitate Learning Teams as a collaborative approach to support cause analysis. The incumbent partners with stakeholders from all areas of the business to ensure actions taken as a result of findings prevent or mitigate the risk of future recurrence. The incumbent ensures effective communications to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines.

WhatYou’llDo
  • Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations.
  • Lead complex and/or high impact investigations. Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
  • Documents investigation reports and findings in designated Quality systems. Ensures required management and Quality approvals on final investigations while satisfying established due dates.
  • Facilitates corrective and preventive action agreement with stakeholders.
  • Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
  • Presents investigations during internal and external audits.
  • Leads investigations for Quality deviations and incidents.

Who YouAre

You enjoy applyingsystematic and analytical cause analysis techniques to investigations. You are skilled atidentifyingthe best methodology for the given situation as well as facilitatinginvestigation team meetings, conductinginterviews, collectingand synthesizing data in order to identify causes that if addressed would prevent recurrence. Operations or Manufacturing experience personnel preferred.

Qualifications

Required Skills
  • A.S./B.S./Master’s degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline
  • Minimum of 5 + years of experience with Master’s; 8 + years of experience with Bachelor’s; 12 + years of experience with A.S., with that experience in a lab and operations environment.
  • Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
  • Strong facilitation skills and proven record to effectively lead cross-functional teams.
  • Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
  • Ability to interpret technical information and documentation used for operations and production activities.
  • Demonstrated experience in performance improvement with basis in Human and Organizational Performance principles.
  • Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
  • Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.

Preferred Skills
  • Industrial/plant experience
  • Operations or Manufacturing experience




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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