Boston Scientific Chemist 

Ireland, Galway 

585321318

Key Responsibilities:

• Primary Commitment to patient safety and product Quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment calibration and qualification as required.
• Review of all laboratory Quality Systems to ensure compliance to cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• 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.
• Perform and assist with additional duties as may be directed by the QC supervisor.
• 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. Where required approve CR’s as laboratory trainer.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory spend and approval of vendor invoices.
• Management of laboratory inventory and supplies and ordering of same.
• Manage laboratory training process and maintenance to training status.
• Provide analytical support to process validations.
• Participate on LBP/VIP and Continuous project teams as required.

Qualifications

• NFQ Level 8 (240 credits) in Science, Chemistry or a relevant discipline
• Min. 3-5 years experience in a similar role ideally in medical devices (not essential)
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.

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