The Synergy Lab Support team supports the Quality Assurance Department at our Customer's 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 focus on sample and material management.
PRINCIPAL ACCOUNTABILITIES:
Operational
Booking in of samples and materials (sample reception, verification, documentation, labelling, logging, test assignment and workflow initiation)
Undertake other Laboratory Support activities as requested by the Synergy Supervisor and Team Leader, which may include
Environmental monitoring excursions, collecting water and air samples to monitor site facilities for any microbial growth
Testing of samples according to pre-defined test methods, specifications or Pharmacopoeia. (Training will be provided.)
Ordering and tracking of general consumables, spares, and equipment, ensuring delivery to correct location, and receipting of goods
Performing and recording daily lab checks
Liaison with other service partners for engineering, waste management, cleaning, maintenance, and infrastructure issues
Coordination of waste disposal including but not limited to, solvents, sharps, discarded samples, solid waste bins
Vial labelling and aliquoting
Archiving of validation and other documentation
Ensure analytical records follow cGMP requirements and ALCOA+ principles (attributable, legible, contemporaneously recorded, original and accurate)
Fulfil ad-hoc customer requests 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.
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
Adheres to current work instructions and SOPs
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
Understanding of COSHH and/or lab safetyCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy