Stability Scientist II

Job Title: Stability Scientist II

About the Role:

We are seeking a highly skilled Stability Scientist II to join our team at ConvaTec. As a Stability Scientist II, you will be responsible for performing physical and analytical stability testing on existing and new medical devices according to pre-determined stability study protocols, SOPs, OCIs, and TDs in support of product shelf-life and product labeling.

Key Responsibilities:

* Analyzing, documenting, interpreting, and reporting laboratory data for stability studies to GMP/GLP standards.
* Support maintenance, calibration, documentation, and updating quality records for Stability equipment.
* Maintain compliance with ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.
* Provide technical knowledge to some stability studies with support from a Senior Scientist.
* Experience with a wide range of analytical equipment such as balances and pipettes through to HPLC and ICP-MS.
* Write shelf-life plans/reports and stability protocols/reports with some support from a Senior Scientist/Specialist.
* Performs Lab/OOS investigations with some supervision incorporating problem-solving and troubleshooting for future improvements.
* Identify when laboratory consumables, chemicals, and reagents are low and request for reorder while continuously improving stock management.
* Perform the drafting of stability documentation such as protocols and reports.
* Write Quality documentation such as Change Control Records, Non-Conformances, and Out of Specifications.
* Ensure the Stability labs are maintained as a safe working environment, raising near misses where needed.
* Support planned and ad-hoc stability sample set-downs, pull requests, and support laboratory tasks as and when required.
* Collation of stability data, including physical data retrieval, for stability/technical reports.
* Assist in the storage and retrieval of stability samples.
* Support any on-site maintenance, service, and calibration activities performed by external vendors.
* Supports and provides information for internal and external audits where required in a timely manner.
* Coordination and organisation of studies from concept to completion including sample retrieval, as advised by senior team members.
* Suggest appropriate accelerated and real-time aging programs that are suitable for the study in concept.
* Actively execute improvement ideas (Lean/6S) for the Stability laboratories and suite.
* Support improvements to current stability processes including updates to test and operating procedures.
* Train new and inexperienced members of staff in test procedures and related equipment calibration/use.

About You:

* Preferably 1-2 years experience working in the Medical Device/Pharmaceutical Industry within an R&D/product development role.
* Ability to react and respond positively to changes in priority and workload.
* Competent in following and adhering to pre-determined stability study protocols, SOPs, OCIs, and TDs.
* Basic experience in the utilisation of computerised systems to manage data and information.
* An active team player disciplined in adhering to group objectives including taking an active role in team collaborative activities.
* Good working knowledge of Microsoft Office - specifically Word and Excel.
* Understanding of compliance with FDA and European Regulations (ICH), Quality Systems, and GMP Guidelines.
* Proactive and positive mindset with an attitude that is open to change to embrace new ways of working and improvements.
* Competent in the disposal of chemicals, reagents, and solvents in accordance with site and environmental procedures.

Working Conditions:

* Working in a laboratory environment with exposure to chemicals, reagents, and solvents.
* Working with various storage chambers (freezer, fridge, incubators etc.) for sample retrieval and deposit.
* Understanding of the role of stability testing within the product development lifecycle.
* Ability to adapt to a changing environment and balance multiple, competing priorities to meet objectives.
* Good working knowledge of laboratory Health and Safety Practices.
* Use of VDU equipment.
* Flexibility of task management and working laboratory environment is essential due to continually changing priorities.

Travel Requirements:

There may be opportunities to attend external training courses which may involve daytime return travel or an overnight stay.

About ConvaTec:

ConvaTec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about ConvaTec, please visit our website.

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