Scientist II - Laboratory Services
Scientist II - Laboratory Services
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Job Description
To perform physical and analytical stability testing on existing and new medical devices and skin care products according to pre-determined stability study protocols SOPs OCIs and TDs in support of product shelf-life and product labelling.
Key Responsibilities:
- Analysing 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 to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.
- Provide technical knowledge to some stability studies with support from Senior Scientist.
- Experience with a wide range of analytical equipment such as balances and pipettes
- Write shelf-life plans/reports and stability protocols/reports with some support from 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 whilst 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 programmes 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.
Skills & Experience:
- Preferably 1-2 years experience working in 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 to site and environmental procedures.
Qualifications/Education:
- . or equivalent in a scientific discipline (e.g. Chemistry Biology).
Dimensions:
- Principal Contacts & Purpose of Contact
- Scientists / Senior Scientists
- Team Leader
- Laboratory Manager
Travel Requirements
- There may be opportunities to attend external training courses which may involve daytime return travel or an overnight stay.
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 tomeet objectives.
- Good working knowledge of laboratory Health and Safety Practices.
- Use of VDU equipment.
WHAT YOULL GET:
- competitive salary & bonus
- exceptional benefits
- training & development
- collaborative & supportive culture
READY TO JOIN US
At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.
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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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Employment Type
Full-Time
