Job Opportunities with Nitto Denko Avecia in the USA
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Why work at Avecia?

As a leading drug development services company for oligonucleotide therapeutics, the first step in our DNA/RNA sequence is to work with a great team of people.

At Avecia, our team approach allows you to excel in your individual area of expertise as well as to be part of a group of professionals that has the support of management and peers from various backgrounds. And while we’re focused on results, we still maintain our flexibility and enjoy camaraderie and the benefits of work/life balance. Make the next move in your progression of success and join Avecia.

At Avecia, we encourage and value people from diverse ethnic and cultural backgrounds to contribute to our collective success. It is Avecia’s policy to conduct business without regard to an individual’s disability or any other protected status. We are fully committed to the concept and practice of equal opportunity and affirmative action in all aspects of employment and encourage all to apply.

Sr. Manager/Associate Director-Quality Investigations

Department: QA
Location:

Description:

Individual is responsible for the management and oversight of Root Cause Investigations and Corrective Action and Preventive Action (CAPA) as well as Non-Conformance (NC) investigations and process activities. Demonstrated leadership in organizing and driving solution based teams. Ensure compliance to process requirements and the consistency/quality of Investigations, CAPA and NCs. Lead, support and train site personnel on conduct of root cause analysis investigations and drive continuous improvement efforts on an ongoing basis. This position may also support the Nitto Avecia Cincinnati site as it related to alignment and CI.

Responsibilities:

  • Partner with all departments and drive continuous improvement on Root Cause investigations and CAPA as a core Quality Business process/function(s).
  • Ensure timely completion of RCA through active participation and management of the investigative process
  • Maintain/report site metrics to demonstrate ongoing status
  • Coordinate CAPA review board and maintain meeting minutes
  • Ensure CAPA investigations are clearly documented and implemented to fulfill regulatory and business requirements
  • Support the rollout of any new Investigation/CAPA solutions (tools, techniques, and/or process enhancements)
  • Manage QA CAPA staff through direct or indirect lines of reporting (as assigned) including setting expectations and providing performance feedback

Position Requirements:

  • Bachelor Degree in Chemistry or Engineering; and 5+years related investigations experience
  • Management experience in a pharmaceutical/biotechnology organization
  • Oligonucleotide, small molecule or peptide process experience preferred.
  • Understanding of CAPA and NC system regulations and standards (e.g. ISO9001, ISO13485, FDA 21CFR820.100)
  • Provides project direction, oversight, coaching, and mentoring for Investigations teams as required.
  • Use technical/compliance information to guide and influence Investigation/CAPA/NC/Compliance strategies.
  • Strong project management and organizational skills excellent verbal and written communication skills.
  • Strong analytical and problem solving skills.
  • Excellent attention to detail, resourceful, self-reliant, self-motivated and confident

Equal Opportunity Employer

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