Stability Scientist II- Laboratory Services
Stability Scientist II- Laboratory Services
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Job Description
Our search for better is changing the lives of our customers. Its changing the careers of our people too creating new challenges and opportunities all the time. Were a business that never stands still. Join us on our journey to #ForeverCaring
The role:
To perform physical and analytical stability testing on existing and new medical devices and skin care products according to predetermined stability study protocols SOPs OCIs and TDs in support of product shelflife and product labelling.
Key Responsibilities:
Analysing documenting interpreting and reporting laboratory data for stability studies toGMP/GLP standards.
Support maintenance calibration documentation and updating quality records for Stabilityequipment.
Maintain compliance to ISO13485 & ISO9001 standards in accordance with GLP/GMPcompliant 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 pipettesthrough to HPLC and ICPMS.
Write shelflife plans/reports and stability protocols/reports with some support from SeniorScientist/Specialist.
Performs Lab/OOS investigations with some supervision incorporating problemsolving andtroubleshooting for future improvements.
Identify when laboratory consumables chemicals and reagents are low and request forreorder whilst continuously improving stock management.
Perform the drafting of stability documentation such as protocols and reports.
Write Quality documentation such as Change Control Records NonConformances andOut of Specifications.
Ensure the Stability labs are maintained as a safe working environment raising nearmisses where needed.
Support planned and adhoc stability sample setdowns pull requests and supportlaboratory 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 onsite maintenance service and calibration activities performed by externalvendors.
Supports and provides information for internal and external audits where required in atimely manner.
Coordination and organisation of studies from concept to completion including sampleretrieval as advised by senior team members.
Suggest appropriate accelerated and realtime aging programmes that are suitable for thestudy in concept.
Actively execute improvement ideas (Lean/6S) for the Stability laboratories and suite.
Support improvements to current stability processes including updates to test anrating procedures.
Train new and inexperienced members of staff in test procedures and related equipmentcalibration/use.
Skills & Experience:
Preferably 12 years experience working in Medical Device/Pharmaceutical Industrywithin an R&D/product development role.
Ability to react and respond positively to changes in priority and workload.
Competent in following and adhering to predetermined stability study protocols SOPsOCIs and TDs.
Basic experience in the utilisation of computerised systems to manage data andinformation.
An active team player disciplined in adhering to group objectives including taking anactive 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 Systemsand GMP Guidelines.
Proactive and positive mindset with an attitude that is open to change to embrace newways of working and improvements.
Competent in the disposal of chemicals reagents and solvents in accordance to site andenvironmental procedures.
Qualifications/Education:
. or equivalent in a scientific discipline (e.g. Chemistry Biology).
Working Conditions
Working in a laboratory environment with exposure to chemicals reagents and solvents.
Working with various storage chambers (freezer fridge incubators etc. for sampleretrieval 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.
Special Factors
Flexibility of task management and working laboratory environment is essential due tocontinually changing priorities.
Our transformation will change your career. For good. Youll be pushed to think bigger and aim for excellence. Your ideas will be heard and youll be supported to bring them to life. Therell be challenges. But stretch yourself and embrace the opportunities and you could make your biggest impact yet. This is stepping outside of your comfort zone.
This is work thatll move you.
#LIAN1
#LIOnsite
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
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Equal opportunities
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.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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Employment Type
Full-Time
