Laboratory Analyst

Laboratory Analyst

Location: Limerick

Contract: 12 Month Contract

The Laboratory Analyst will be responsible for completing day to day operations of the laboratories, in accordance with relevant regulatory requirements and lab standards for medical devices. The Laboratory Analyst will adhere to sustained levels of product quality, manufacturing and chemistry compliance.

What you will do:

Will work within the chemistry team, under direct supervision, with responsibility to carry out duties under effective and efficient chemistry & laboratory practices, which includes, but not limited to the following:

• Complete sampling / testing of raw materials, intermediate and finished products. Testing includes physical and chemical testing , (e.g.: PSA, FTIR, ATR, XRD, Mechanical Strength Testing)

• Complete routine verification activities.

• Provide business support, as applicable

• Understands role and the importance of meeting the requirements of the Laboratory.

• Understands the business requirements and potential implications owning to any failures to deliver products and services within the agreed timeframe / standard to Production and support functions.

• Complete ordering and control of consumables and testing chemicals.

• Complete documentation review / storage - verification and GMP checks on all raw data / logbooks / records.

• Filing and archiving of records.

• Control of documentation associated with Raw Material Receiving Inspection, Traceability and other Quality Records that are to be maintained by the Laboratory.

• Control of Retain Sample areas (on-site and off-site) and overall process.

• Co-ordination of the testing which is out-sourced and liaises with Contract Laboratories.

• Execute Laboratory Equipment Qualifications and Test Method Validations.

• Own “out of specification” investigations and perform relevant testing.

• Progress updates through the QMS. Own related changes.

• Complete the Originator task for change control. · Support to Laboratory training programme.

• Support Company and laboratory initiatives.

• Participate in both Internal and External Audits within Stryker.

• Own and drive identified cost savings.

• Provide recommendations to support the business, continuous improvements in test methodologies / laboratory systems.

What you will need:

• Degree in Chemistry or related subject

• Experience in a Quality/Regulatory Affairs environment desirable.

• Ability to build knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Chemistry)

• Must possess strong communication skills as well as have the ability to manage multiple tasks simultaneously.

• Strong interpersonal skills.

• Demonstrated ability to work independently.

• Ability to be proficient in statistic techniques, data review and analysis.

• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages

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