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.

Manufacturing Compliance Lead

Department: Manufacturing
Location:

 

Purpose of Position:

The Manufacturing Compliance Lead position is responsible for the management of all compliance (Quality and Safety) investigations, corrective actions, and continuous improvement of system within the Manufacturing group. This person will demonstrate leadership in organizing and driving data based problem solving for the team as well as working with Manufacturing managers, supervisors, and leads to assure the growth and maintenance of a quality and safety compliance culture.

Key Responsibilities:

  • Leads the Manufacturing Compliance team to assure all compliance goals and objectives for the group are met and regularly reported.

  • Facilitate, document, and review compliance related investigations to ensure root causes are identified, corrective actions implemented, and the effectiveness of these corrective actions fulfill regulatory and business requirements.

  • Develop, maintain, and continually improve all compliance KPIs for the department and report to the Management Review team on an established periodic basis.

  • Routinely audit all quality and safety compliance systems including safety analysis/risk assessment, 5S, training, documentation, and general manufacturing operations to assure continual compliance.

  • Perform data trending and data analysis to anticipate areas of improvement, implement the improvement, and measure the results.

  • Provide recommendations as required for improvement to senior management based on data trending and analysis.

  • Seek and lead training opportunities for manufacturing staff in the areas of quality and safety compliance.

     

  • Drive continuous improvement of systems to improve overall organizational effectiveness and efficiency.

  • Provide technical writing support for high level quality investigations and assure standards for investigational reporting are met.

Job Knowledge Required:

  • A BS in a technical discipline is required, Chemistry , Biology, Engineering preferred.

  • 5-10 years of experience in a cGMP pharmaceutical manufacturing environment with a strong understanding of quality requirements for the industry.

  • Must have demonstrated experience leading departmental and cross-functional teams through effective peer-to-peer influence.

  • Lean/SS certification is strongly preferred.

  • Must have strong technical writing and communication skills.

  • Must have experience leading root cause analysis.


Equal Opportunity Employer

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