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Quality Assurance Specialist II Job

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Date: Sep 26, 2021

Location: Galway, Ireland

Company: Boston Scientific

More than the opportunity of a lifetime......the opportunity to improve lives 

For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine.  The Company's products help physicians and other medical professionals improve their patients' quality of life by providing alternatives to surgery.  Since 1994, employees in Galway have been at the forefront of some of these truly innovative medical device designs and manufacturing. 

Due to continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Quality Assurance Specialist II.

 

Purpose

  • Provide Independent Quality Assurance Support to the Operations Analytical laboratory. Maintains, develops and implements laboratory methodologies, systems and practices. Provide independent guidance to the analytical lab while ensuring compliance to procedure and cGMP requirements.

 

Responsibilities

  • Provides quality assurance support and direction to the analytical laboratory responsible for the testing and release of all drug combination products and raw materials used on the site.

  • Responsible for ensuring that Raw Materials, Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP both in BSC laboratories and at the contract laboratories. 

  • The QA Specialist shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, and Technical Investigation.

  • The role also requires working with the cross functional groups including Product Release, Supply Chain Planning, Shipping and Distribution groups. 

  • Preparation and compilation of Annual Product reviews on DES Products

  • Schedule and complete laboratory assessments

  • Provide the independent review of NCEP’s and eCAPA

  • Review and approval of equipment/ software testing method validation

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Education/Qualifications & Experience:

  • NFQ Level 8 Qualification (240 credits) in science or related engineering discipline.

  • Minimum of 3-5years in a similar role.

  • Experience working in the pharmaceutical or biotechnology industry is essential.

  • Excellent written and verbal communication skills.

  • Experience working with dynamic cross functional teams and prove abilities in decision making.

  • Strong organisational skills including ability to follow assignments through to completion.

  • Detailed knowledge of applicable regulatory requirements.

  • LIMS/SAP/Empower while not necessary is an advantage

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 


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