The successful candidate will be part of a team that transfers the manufacturing process of a medical device product and the transfer of an Analytical Chemistry lab from a site acquired by Boston Scientific.
The purpose of the Chemist role is to support the set-up of the new Analytical Chemistry lab in the Boston Scientific Cork site.
The role will be responsible for the development and qualification of analytical test methods.
The role will also involve conducting analytical testing on validation, commercial, stability, and non-routine samples.
They are responsible for ensuring that all testing is carried out in accordance with cGMP.
This role will work with the site transfer team to ensure compliance with the quality system and that transfer project timelines are met.
The role will initially require travel to the site acquired by Boston Scientific to understand the analytical tests to be transferred.
Key Responsibilities Evaluate & validate analytical methods across a range of techniques (including UPLC, GC, and FTIR) as required to support product transfer.
Raw material, in-process, and finished product testing.
Ensure all analytical testing is carried out as defined in the Quality System.
Perform equipment calibration and qualification as required.
Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant with cGMP.Complete documentation associated with testing/method development & validation/equipment qualification in a timely manner.
Review all laboratory Quality Systems to ensure compliance with cGMP.Demonstrate problem-solving in delivering process and analytical understanding.
Provide training (induction/on the job/procedures and updates), technical guidance/troubleshooting to laboratory staff including review of associated training records.
Review and approval of laboratory results and documentation, as required, and the trending and charting of data.
Proficient in the use of various software applications utilized in the laboratory.
As required, develop, configure, and validate software in accordance with Boston Scientific and industry standards.
Create, review, and approve change requests as required.
Management of laboratory equipment, inventory & spend.
Be able to communicate clearly and form strong working relationships with colleagues.
Work on own initiative and be capable of developing solutions to problems as part of a team.
Willing to operate flexibly and be able to switch priorities at short notice.
Be a good team player, organized, accurate, and have strong documentation skills.
Education BSc in Chemistry or similar, minimum.2-3 years' GMP experience as a Chemistry Analyst is required for this role.
Boston Scientific is an Equal Opportunity Employer.
At Boston Scientific, we are committed to providing an inclusive recruitment process.
Should you require reasonable accommodation during the application or recruitment process, please email
as we are here to support you throughout your candidate journey.
A member of the TA Ireland team will contact you directly within 48 hours of receipt of your email.
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