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 Manager/Senior QA Manager

Department: QA
Location:

Purpose of the Position: 

 Oversees the development, implementation and maintenance of quality assurance systems and activities in cGMP environment.  Oversees generation and review of documents used in good manufacturing practices including but not limited to quality investigations and batch release.  May audit raw material vendors and prepare manufacturing documentation for updated filing. 

Job Responsibilities: 

  •  Writes SOPís, protocols, validation plans and compliance documents for cGMP program. 
  •  Sets-up and oversees cGMP program for manufacture of Active Pharmaceutical Ingredients. 
  •  Acts as departmental resource for cGMP programs. Leads quality investigations related to OOS, Deviation and CAPA programs.
  •  Interfaces with prospective clients on cGMP audits then responds in writing to findings. 
  •  Interfaces with FDA during audits. 
  •  Sets-up and organizes tracking program for equipment used in cGMP work. 
  •  Reviews and authorizes batch production records and quality control documentation and dispositions executed batches 
  •  Solves complex, non-routine analytical and product problems independently. 
  •  May perform compliance audits of suppliers, contract labs and vendors then writes audit reports. 
  •  Performs internal audits and ensures observations are corrected. 
  •  Sets-up and tracks material flow and material-labeling process to ensure compliance with cGMP program. 
  •  Responsible for implementation and maintenance of automated documentation control system 

 

QUALIFICATIONS/EXPERIENCE/SKILLS REQUIRED:  

  •  BS/BA in science with 5+ years of Quality Assurance cGMP experience in the area of Active Pharmaceuticals and 3 + years of supervisory experience 
  •  Ingredients (API) manufacturing or related GMP experience. 
  •  High level of knowledge in cGMP regulations for pharmaceutical products and related guidelines such as ICH Q7A. 
  •  Experience conducting quality investigations, root cause analysis and quality risk assessments. 
  •  Experienced in auditing suppliers, analytical contract labs and vendors. 
  •  Knowledge of annual product review and stability study protocols per ICH. 
  •  Solves complex, non-routine analytical problems. 
  •  Trains and supervises others in area of cGMP. 
  •  Very strong oral and written communication skills. 

Equal Opportunity Employer

 

  

 

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