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Date: Jun 11, 2021

Location: Cork, C, IE

Company: Boston Scientific

Location: Cork, Cork (IE-C), Ireland (IE)
Req Number: 483423 
Hiring Manager: Cormac McCarthy

 

 

Purpose Statement:

The successful candidate will be part of 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 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.

This role will work with the site transfer team to ensure compliance with the quality system and transfer project timelines are met.

The role will initially require travel to site acquired by Boston Scientific to understand the Analytical tests to be transferred.

The role will also involve conducting analytical testing transfer, validation, preparation of documentation and requires a keen level of understanding of the requirments for an anytical method transfer, including instrument and software qualification. They will be  responsible for ensuring that all testing is carried out in accordance with cGMP.

 

Responsibilities:

 

  • Evaluate & validate analytical methods across range of techniques (including UPLC, GC) as required to support product transfer.
  • Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
  • 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 to cGMP.
  • Review of all laboratory Quality Systems to ensure compliance to cGMP.
  • Demonstrate problem solving in delivering process and analytical understanding.
  • Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
  • Review and approval of Laboratory results and documentation, as required the trending and charting of data.
  • Proficient in the use various software application utilized in the laboratory. As required the development configuration and validation of 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 to 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 in a flexible manner and be able to switch priorities at short notice.
  • Be a good team player, organized, accurate, have strong documentation skills.
  • Train to Boston Scientific’s Quality system documentation e.g. Change Control and Analytical Test Method Validation etc. Create, review and approve change requests as required.
  • Demonstrate problem solving in delivering process and analytical understanding.
  • Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
  • Willingness to travel

 

Requirements:

Level 8 in a relevant chemistry discipline

Demonstrated ability to make key SME decisions

Problem Solving and analytical skills required

Strong at stakeholder management and collaboration

 

At Boston Scientific, we draw strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion

Equal Employer Opportunties


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