Chemist I

Chemist I

Boston Scientific

Galway, Ireland

Job Purpose:

As the Chemist, P1 you will ensure patient safety and product quality through rigorous compliance with cGMP standards. You’ll perform analytical testing, method development, and validation while driving continuous improvement in laboratory systems. Ideal candidates are detail-oriented, technically skilled, and passionate about quality excellence.

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 your direct line manager.
• 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.
• 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 VIP and Continuous project teams as required.

Preferred Education & Experience:

• Honours Bachelor Degree (level 8) in Science, Chemistry or a relevant discipline.
• Min. 2 years’ experience in a similar role ideally in medical devices.
• Strong experience in HPLC and FT-IR analysis would be an advantage.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.