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 Specialist I

Department: QA
Location:

How can you make a difference in this role?

The position is responsible for documenting and auditing cGMP practices for the site.   The position develops and revises QA procedures to strengthen cGMP compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.


What are the key responsibilities of this role?

·        Reviews quality records/batch records

·        Plays a key role in the cGMP compliance activities at the Milford site by preparing the site for FDA Pre-approval Inspections (PAI) and continuously works with other departments to maintain and monitor compliance with cGMPs.

·        Reviews and releases raw materials

·        Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.

·        Assist senior staff in conducting internal CGMP audits and supplier audit as needed. 

·        Strong attention to detail and self-checking skills  

 

What experience and job knowledge do you need to excel in this role?

The position requires BS/BA in science or with 1-5 years experience in either production or Quality Assurance. Strong knowledge of a cGMP regulation. Training and experience in quality systems, quality audits, documentation, change control, corrective preventative action and review of quality records is required. 

 

Equal Opportunity Employer

 

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