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Quality Assurance Investigation Specialist

We have an exciting new opportunity for a driven and motivated team-player with laboratory/manufacturing experience to join our small but dynamic team in Hillerød.

Job Description

As Investigator, you will be responsible for maximizing organizational learning and improvement from Quality and Safety deviations. You will apply systematic and analytical cause analysis techniques inclusive of Human and Organizational performance principles to each investigation assigned.

You will identify the best methodology for the given situation, facilitate investigation team meetings, conduct interviews, and collect and synthesize data in order to identify causes that if addressed would prevent recurrence.

In some situations, you will facilitate Learning Teams as a collaborative approach to support cause analysis and you will cooperate 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.

Primary Responsibilities

  • Conducts Quality and Safety investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations
  • Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
  • Documents investigation reports and findings in designated Quality and Safety systems. Facilitates corrective and preventive action agreement with stakeholder
  • Facilitates internal sharing of investigational findings and risk knowledge
  • Ensure effective communications to stakeholders and manage activities to ensure completion per expected regulatory and product release timelines
  • Ensure investigations are conducted in alignment with Quality Management System requirements and governing safety regulations, and presents investigative findings during audits as requested

Qualifications

  • Relevant experience in a lab and/or manufacturing environment (industrial/plant experience preferred)
  • Experience in systematic cause analysis methods and good facilitation skills
  • Good technical writing skills and the 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
  • Able to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems
  • Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy
  • Experience in management of diverse stakeholders and ability to communicate effectively across organizations
  • Strong oral and written communication skills
  • Practical knowledge of performance improvement and application of compliance regulations and inspections.

Education

  • Bachelor/Master’s degree in Science or similar degree, preferably with process knowledge


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