Location: Anngrove, Carrigtwohill
Contract: 12 Month (Maternity Leave)
Shift: 24/5 (2 Days, 2 Nights, & 4 Days Off on Rotation). (7.00 - 7.00)
Position Summary
Conduct testing of analytical samples for Production. Conducts work in compliance with cGMP, safety and regulatory requirements. May provide analysis and evaluation of material and products at all stages of development process. Assists in developing and validating testing methodology used to control raw materials, production intermediates and final products. Helps establish, validate and document new or existing compound identification methods.
This position requires knowledge that is acquired through experience, specialized education or training. The role has clearly defined procedures and tasks as well as defined guidelines to aid in decision making. The job should possess a good knowledge and comprehensive understanding of the range of processes, procedures and systems to be used in carrying out assigned tasks and a basic understanding of the underlying concepts & principles upon which the job is based. The knowledge can be acquired through a combination of job-related training and considerable on-the-job experience.
What You Will Do:
* The successful candidate 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.
* Complete routine verification activities.
* Provide business support, as applicable.
* Understand the role and the importance of meeting the requirements of the Laboratory.
* Understand 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 and sample retains.
* Execute Laboratory Equipment Qualifications and Test Method Validations.
* Own “out of specification” investigations and perform relevant testing.
* Progress updates through the QMS.
* Drive identified cost savings.
* Provide recommendations to support the business, continuous improvements in test methodologies / laboratory systems.
What You Will Need:
* Bachelor degree/ Masters of Microbiology or equivalent.
* 2+ years experience in Quality/Regulatory Affairs environment.
* 2 years Microbiology related experience.
* Experience in interacting with regulatory agencies (FDA, BSI, etc.).
* Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology).
* Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
* Strong interpersonal skills.
* Strong written and oral communication and negotiations skills.
* Strong in critical thinking and "outside the box" thinking.
* Highly developed problem solving skills.
* Strong analytical skills.
* Demonstrated ability to successfully manage and complete projects in a matrix organization.
* Demonstrated ability to work independently.
* Experience in working in a compliance risk situation.
* High proficiency in statistical techniques, data review and analysis.
* High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
* Some travel may be required.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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