Stability Scientist II
7 days ago
We are seeking a highly skilled Stability Scientist II to join our team at ConvaTec. As a key member of our R&D department, you will be responsible for performing physical and analytical stability testing on existing and new medical devices.
Key Responsibilities- Analyzing, documenting, interpreting, and reporting laboratory data for stability studies to GMP/GLP standards.
- Supporting maintenance, calibration, documentation, and updating quality records for Stability equipment.
- Maintaining compliance with ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.
- Providing 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.
- Writing shelf-life plans/reports and stability protocols/reports with some support from a Senior Scientist/Specialist.
- Performing Lab/OOS investigations with some supervision incorporating problem-solving and troubleshooting for future improvements.
- Identifying when laboratory consumables, chemicals, and reagents are low and requesting for reorder while continuously improving stock management.
- Drafting stability documentation such as protocols and reports.
- Writing Quality documentation such as Change Control Records, Non-Conformances, and Out of Specifications.
- Ensuring the Stability labs are maintained as a safe working environment, raising near misses where needed.
- Supporting planned and ad-hoc stability sample set-downs, pull requests, and supporting laboratory tasks as and when required.
- Collating stability data, including physical data retrieval, for stability/technical reports.
- Assisting in the storage and retrieval of stability samples.
- Supporting any on-site maintenance, service, and calibration activities performed by external vendors.
- Supporting and providing information for internal and external audits where required in a timely manner.
- Coordinating and organizing studies from concept to completion including sample retrieval, as advised by senior team members.
- Suggesting appropriate accelerated and real-time aging programs that are suitable for the study in concept.
- Actively executing improvement ideas (Lean/6S) for the Stability laboratories and suite.
- Supporting improvements to current stability processes including updates to test and operating procedures.
- Training new and inexperienced members of staff in test procedures and related equipment calibration/use.
- 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 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.
There may be opportunities to attend external training courses which may involve daytime return travel or an overnight stay.
We are committed to providing a safe and inclusive work environment for all our employees. If you are interested in this role, please submit your application through our official website.
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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Stability Scientist II
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Deeside, Flintshire, United Kingdom ConvaTec Full timeAbout the RoleWe are seeking a highly skilled Stability Scientist II to join our team at ConvaTec. As a key member of our R&D department, you will be responsible for performing physical and analytical stability testing on existing and new medical devices.Key ResponsibilitiesAnalyzing and documenting laboratory data for stability studies to GMP/GLP...
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Stability Scientist II
2 weeks ago
Deeside, Flintshire, United Kingdom ConvaTec Full timeAbout the RoleWe are seeking a highly skilled Stability Scientist II to join our team at ConvaTec. As a key member of our R&D department, you will be responsible for performing physical and analytical stability testing on existing and new medical devices.Key ResponsibilitiesAnalyzing and documenting laboratory data for stability studies to GMP/GLP...
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Deeside, Flintshire, United Kingdom ConvaTec Full timeAbout the RoleWe are seeking a highly skilled Stability Scientist II to join our team at ConvaTec. As a key member of our R&D department, you will be responsible for performing physical and analytical stability testing on existing and new medical devices.Key ResponsibilitiesAnalyzing and interpreting laboratory data for stability studies to GMP/GLP...
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Deeside, Flintshire, United Kingdom ConvaTec Full timeAbout the RoleWe are seeking a highly skilled Stability Scientist II to join our team at ConvaTec. As a key member of our R&D department, you will be responsible for performing physical and analytical stability testing on existing and new medical devices.Key ResponsibilitiesAnalyzing and interpreting laboratory data for stability studies to GMP/GLP...
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