Document Controller - Cambridge, United Kingdom - Lightcast Discovery
Description
Our mission is to push the boundaries of complex cell analysis. Using the Lightcast platform we are working with major pharmaceutical companies and leading academic institutes.Together, using our next generation microfluidic platform, we are making advances towards new science, unique clinical approaches, new therapies and innovative products.
The Lightcast platform allows precise and highly flexible independent control of thousands of microdroplets independently and in parallel using software-generated light patterns.
By combining droplets containing different cells, antibodies, cancer drugs, reporters and /or other reagents we can perform complex workflows and assays with a flexibility far beyond what is currently possible on any cell analysis platform.
About the role
Your responsibilities will include:
- Support QA documentation activities related to Product Development and Manufacturing.
- Assist with planning & coordination of internal audits and ensure audit nonconformances are logged and followed up for completion'
- Experience in Quality support processes, such as Supplier control, change control, Nonconformance, CAPA (Corrective, and Preventive Actions), deviation, complaint investigation and Continuous Improvement preferred
- Assist with Suppliers & Customers (internal/external) on document related queries as efficiently as possible without compromising Quality and Safety standards
- Monitoring of Quality KPI's and input to management review
- Aiding in writing procedures, instructions, protocols, risk assessments & specifications, and carry out any relevant document management system updates.
- Review development documents and other QMS system documents, support risk management outputs.
- Experience in technical file compilation
- Identifying and implementing areas for improvement within the QMS.
- Safety is everyone's responsibility
- A degree (or equivalent) Chemistry or Bioscience
- Knowledge and understanding of ISO9001 or equivalent standard (AS9100, ISO 13485)
- Working within QA environment of manufacturing /product development preferable
- Minimum 2 years' working experience in Quality
- Competent IT skills, skills in other electronic systems such as document management systems, Quality Management Systems, NC/CAPA, complaints.
- Selfstarter with good communication skills and attention to detail.
- Excellent organisational, planning, and time management skills with hands on approach
- Proficient in Microsoft Office (Word, Excel, Powerpoint and Outlook)
- 26 days holiday, plus Public Holidays
- Flexible working hours
- Pension contribution matched up to 7%
- Private medical insurance
- Income protection
- Life insurance
- Subsidised gym membership and weekly cross fit sessions
- Access to Cycle to Work and Technology schemes
- Enhanced family leave policies
Here at Lightcast Discovery we have an informal, open work environment where collaboration and innovation are at the heart of what we do.
At Lightcast, we recruit on a rolling basis, meaning we carry on recruiting until we find the right person for the role being advertised.
About Lightcast**Lightcast Discovery is committed to equal employment opportunity regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
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