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.

QA Compliance Manager

Department: QA
Location:

Purpose of the Position:

Manage the Investigation/CAPA system in Quality Assurance in conjunction with key stakeholders in other departments and oversee all aspects of vendor assurance including qualification, change control management and risk assessments to comply with the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. In addition, this position will be also support other QA activities as needed.

Key Job Responsibilities:

  • QA point person for investigation/CAPA management.

  • Manage system for the follow-up and resolution of corrective and or preventative action indicated or recommended as a result of any cGMP investigation system

  • Responsible to have a robust system for supplier management including qualifying, change management and quality agreements.

  • Assist in conducting scheduled internal and external quality audits

  • Assure proper evaluation and approval of changes to processes, equipment and manufacturing support systems, obtaining client approval when required.

  • Prepare and maintain the necessary regulatory documentation to be submitted in support of manufacture of APIís

    Job Knowledge Required:

  • Minimum of a BA/BS degree with 5-7 years Quality Systems experience in an FDA-regulated industry.

  • Strong written and verbal communication skills

  • Minimum of 2-3 years managerial experience

  • Ability to work independently in problem solving skills and participate as a team member to resolve complex problems.

  • Strong Interpersonal skills

  • Strong attention to detail and self-checking skills

  • Familiarity with FDA regulations and policies

  • Ability to remain current on the frequently changing regulatory and CGMP requirements

  • As the regulatory and GMP requirements frequently change, the jobholder must also maintain current knowledge

Equal Opportunity Employer

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