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 Project Support Specialist I

Department: Manufacturing
Location: Milford, MA

Purpose of Position:

  • To serve as a data collector for the manufacturing team and the project management team to assure all manufacturing related activities and expectations are communicated to manufacturing resources management. In addition to this responsibility the person in this role would also have some responsibility in the maintenance of one or more of the key compliance systems for the manufacturing department.

Key Responsibilities:

  • Responsible for the implementation of assigned procedures working within defined schedules.
  • Responsible for performing all work within company and cGMP regulatory compliance.
  • Maintaining a safe work environment and following all site safety procedure.
  • Responsible for staying current with the prescribed training curriculum specified for the job title.
  • Assemble training packages for training for new employees

  • Maintains Q.A. Documentation located in the Manufacturing area

  • Provides support for solution batch record review. Oracle allocations, creating and closing Oracle batches.

  • Will write and review documents for both synthesis and purification.

  • Will perform verifications of Oracle transactions for batch and solution records.

  • Responsible for staying current with the prescribed training curriculum specified for the job title.

  • Assist departmental managers with coordinating cross functional activities for corrective actions, continuous improvement efforts and other projects as required
  • Provides support for solution batch record review. Oracle allocations, creating and closing Oracle batches.

  • Will write and review documents for both synthesis and purification.

  • Will perform verifications of Oracle transactions for batch and solution records

  • Will provide training for manufacturing personnel on CAPA. Will set up and present CAPA training for manufacturing and facilities.

Compliance Function

  • Assist originators of investigations to determining root cause.
  • Identify areas of deficiency and or improvement and implement appropriate corrective action followed by monitoring of key performance data to determine effectiveness.
  • Monitor and assist the management of quality documentation to assure timely closure in accordance with company procedures.
  • Work closely with area supervisors to assure operations are performed in full compliance with prescribed procedures.
  • Will serve as a liaison for the manufacturing group with the supply chain group for receiving of all Oracle batches and materials

 

Training and Documentation Functions:

  • Monitor documentation performance and propose solutions for more efficient and improved document performance.
  • Revise generic documentation to keep up with industry standards and customer expectations.
  • Coordinate with technical experts to develop and deliver proficiency level training to direct manufacturing staff.

Job Knowledge Required:

  • This is specialist position requiring a comprehensive knowledge of the cGMP requirements for API manufacturing or pharmaceutical manufacturing.
  • Minimum education requirements include a science related Bachelor’s degree or equivalent work experience.
  • Knowledge of chemical/biotechnology manufacturing processes and equipment is required.
  • Knowledge of oligonucleotide chemistry is preferred.
  • Knowledge of core manufacturing principles such as process efficiencies, optimization, and commercial viability is required.

Equal Opportunity Employer

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