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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:
Operational
* Organise and perform regular environmental monitoring excursions, collecting water and air samples as per current work instructions & SOPs to monitor site facilities for any microbial growth
* Prepare and perform microbial limit testing, including medial preparation, subculturing and incubation.
* Record and prepare samples for different microbiological tests, completing required compliance documentation
* May 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 Leader
* Take active role in Continuous Improvement (CI) and sustainability activities, e.g., Kanban stock levels, 5S, recycling
* Take active role in general lab housekeeping
* Take part in cross training activities and provide cover for other members of the team as required
Customer
* The 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 Environment
Compliance
* Responsible 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 dates
People
* Maintains 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 Supervisor
* Customer and Synergy Team members
* Customer stakeholders: Lab Leads, Compliance, EHS, Quality
PERSON SPECIFICATION:
Experience And Qualifications
* A-Levels in science, HND in a scientific discipline, or equivalent experience (preferred, although full training will be provided)
* Proficiency in problem solving
* Customer service focus, ability to work as a cohesive team
* Good planning and organisational skills with excellent attention to detail
* Computer literacy and competence Microsoft office - e.g., Outlook, Excel, Word
* Effective verbal and written communication skills
* Enthusiasm to work in a busy laboratory environment
Desirable:
* Experience of working to work instructions and SOPs / Risk Assessments
* Experience of Continuous Improvement activities
* Experience of working within a regulated environment
* Experience of working within a laboratory / manufacturing / quality environment
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
TITL1_UKTJ
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Technology, Information and Internet
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