Job Description
CORE RESPONSIBILITIES:The Synergy Lab Support team supports the Quality Assurance Department at the site in Ware, ensuring that all aspects of the manufacture of medicinal products are performed in a controlled manner and meet commitments to international regulatory bodies as well as the requirements of current Good Manufacturing Practice.The role holder will be part of the Synergy Lab Support team, working closely with the wider Synergy team and Customer scientists across various departments. They will undertake a range of lab support activities with a specific focus on Microbiology functions and Environmental Monitoring (EM) activities.PRINCIPAL ACCOUNTABILITIES:OperationalOrganise and perform regular environmental monitoring excursions, collecting water and air samples as per current work instructions & SOPs to monitor site facilities for any microbial growthPrepare and perform microbial limit testing, including medial preparation, subculturing and incubation.Record and prepare samples for different microbiological tests, completing required compliance documentationMay perform testing of samples according to pre-defined test methods, specifications or Pharmacopoeia. (Training will be provided.)Ensures analytical records follow cGMP requirements and ALCOA+ principles (attributable, legible, contemporaneously recorded, original and accurate)Fulfil ad-hoc customer requests for testing to make sure smooth running of the supply chain Take responsibility for assigned items of laboratory equipment or 5S standards.Be responsible for the safety of self and others within the Laboratory.Undertake other Laboratory Support activities as requested by the Synergy Supervisor and Team LeaderTake active role in Continuous Improvement (CI) and sustainability activities, e.g., Kanban stock levels, 5S, recyclingTake active role in general lab housekeepingTake part in cross training activities and provide cover for other members of the team as requiredCustomerThe role holder is accountable for ensuring that all activities are delivered demonstrating behaviours and values aligned to Synergy's Code of Conduct and supporting policies, standards, and procedures, including Health and Safety and EnvironmentComplianceResponsible for ensuring that Laboratory work areas maintain high standards of housekeeping and meet requirements such as 5S.Responsible for ensuring equipment used is calibrated, validated and fit for use, deficiencies are resolved promptly in consultation with the responsible person or expert user.Analysis is undertaken safely and compliantly as per training,Responsible for escalating any laboratory issues, such as safety, compliance and analytical issues giving rise to invalid data.Ensures sample solutions, standards and test media are used within expiry datesPeopleMaintains up to date training records, as well as performance and development plans.Proactively provides feedback on the quality and effectiveness of training as it is received.Communicates needs for any refresher training and keeps training plan up to date via the local system.Key Working Relationships:Synergy Team Leader and Synergy Lab Support SupervisorCustomer and Synergy Team membersCustomer stakeholders: Lab Leads, Compliance, EHS, QualityPERSON SPECIFICATION:Experience and QualificationsA-Levels in science, HND in a scientific discipline, or equivalent experience (preferred, although full training will be provided)Proficiency in problem solvingCustomer service focus, ability to work as a cohesive teamGood planning and organisational skills with excellent attention to detailComputer literacy and competence Microsoft office - e.g., Outlook, Excel, WordEffective verbal and written communication skillsEnthusiasm to work in a busy laboratory environmentDesirable:Experience of working to work instructions and SOPs / Risk AssessmentsExperience of Continuous Improvement activitiesExperience of working within a regulated environmentExperience of working within a laboratory / manufacturing / quality environmentCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.TPBN1_UKTJ