Careers at ERBA Molecular
Thank you for taking an interest in the career opportunities at ERBA Molecular; we are a successful and dynamic company that is always looking to add the right candidate to our team.
ERBA Molecular is a molecular IVD company with a novel, commercially validated and integrated diagnostic system. ERBA Molecular’s approach to simplified workflow employs proprietary sample preparation innovations that integrate with ERBA Molecular’s next generation isothermal amplification technologies as well as existing amplification methods. Together with ERBA Molecular’s unique real-time detection system this combination provides a low cost, easy to use molecular solution for near-patient or decentralised testing.
If you have a BSc or higher and wish to have an opportunity to learn about cutting edge molecular diagnostic technologies we would like to hear from you. Working at ERBA Molecular you will have the opportunity to learn how the scientific team integrates the disciplines of bioinformatics, wet chemistry, assay design and optimisation. The team at ERBA Molecular combine those skills to develop easy to use robust assays within our highly efficient development cycle time.
To find out more about ERBA Molecular follow this link to our Linkedin page
Purpose of the job:-The Quality Specialist is responsible for acting as management representative in the Quality Management System; documenting and maintaining the Quality Management System and maintaining its effectiveness in accordance with the requirements of relevant international standard(s) on behalf of the company and its affiliates.
- Act as management representative in the Quality Management System: responsible for establishing, implementing, maintaining and improving the QMS and promoting awareness of customer and regulatory requirements throughout the organisation.
- Achieve and maintain ISO13485 certification for the organisation.
- Maintain a quality management system which includes:
- documented statements of a quality policy and objectives;
- a quality manual;
- documented procedures and records required by international standard ISO 13485;
- documents needed by the organisation to ensure effective planning, operation and control of its processes;
- any other documentation specified by national or regional regulations;
- a robust and compliant CAPA, complaint, NCR, internal audit process; and
- supplier management processes.
- Manage the day to day aspect of document control and issuance of training records related to QA, manage the training matrix reflecting and identify gaps in training per operator role. Work with team leaders to advise on required training and deliver training on quality SOPs.
- Identify the processes needed for the quality management system, their interactions, and their application throughout the organisation.
- Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
- Ensure the availability of information necessary to support the operation and monitoring of these processes.
- Lead the business in problem resolution and root cause analysis methodology in order to identify corrective and preventive actions and minimise the risk of (re)occurrence. Support operators in investigations and provide guidance where required on non-conformances and planned deviations.
- Support the development of LEAN methodology while driving improvements across the business.
- Build effective relationships with all Erba Molecular staff, creating a culture of Quality by Design and open communication between the Quality department and other departments.
- Measure operators’ engagement with the Quality System on a regular basis and obtain feedback on areas to improve, while remaining compliant at all times. Design and carry out own activities to promote Quality within the organisation.
- Conduct spot checks and internal quality audits regularly and in a supportive constructive manner, coordinate a review of the results and ensure corrective actions are agreed and implemented in the timescales set.
- Drive quality and business improvement opportunities to deliver customer fulfilment, reduced waste and higher profitability.
- Promote a positive health and safety culture in the workplace by following the training received and complying with all health and safety procedures.
- Supporting and working with lab manager\facilities to implement corrective actions with regards to non-conformities
- Degree level or equivalent experience with either a Scientific, Management, Quality or Engineering background
- At least 2 years’ experience in Quality management in either ISO9001, ISO13485 or GMP
- Experience in receiving/hosting audits (customer or notified bodies)
- Experience of promoting Continuous Improvement
- Experience in training non-QA personnel and promoting Quality within the organisation
- Knowledge of new IVDR regulation
- Quality experience within the IVD industry
- Life science technical experience
- Communication Skills:
- Can present effectively at team/company meetings and, when appropriate, outside audiences
- Confident in training others and ensures own expertise is disseminated as widely as necessary
- Can communicate at all levels and bring a culture of employee engagement to the QMS through own positive supportive communications to employees
- Suggests improvements/solutions to practical problems or procedures
- Responds to the needs of team members and provides help in areas of own expertise
- Cooperates and commits to the objectives of team
- Organised in managing quality documentation on a daily basis
- Self-starter and able to work independently
- Microsoft Sharepoint 2010 knowledge