Senior Quality Assurance Associate (Permanent)
- Location: Hertfordshire, UK
- Salary: 40,000 GBP, (starting salary dependant on experience)
- Demonstrated ability to handle flow cytometry and qPCR under GMP regulations
About the Company
A purpose driven company hiring talented and ambitious minds to help us on our mission to curing cancer. Our company is focused on the generation and development of novel cell and gene therapies to help patients overcome cancer. Our research concentrates on expanding our current efforts to enhance a series of next-generation cell and gene therapies.
About the Role
As a Senior Quality Assurance Associate you will be responsible for developing our analytical method testing to support clinical trials. You will have a heavy focus on developing assays employing the use of qPCR. This needs to be in compliance with quality and safety guidelines. You will also be responsible for training other laboratory staff.
- Support Quality Assurance team by reviewing and improving changes impacting T cell therapy product.
- Processingoflaboratory records, procedures and systems in line with GMP standards.
- Create,review,andrevise SOPs and protocols in support of GMP production, including tech transfers and equipment qualification/validation at CMOs.
- Conduct training other laboratory staff on GMP and GDP processing.
- Execute investigations for deviations for manufacturing, testing and shipping of raw materials or drug product.
- Design and implement CAPA to improve product quality.
- Support with approval of suppliers, contractors and service providers and assist with external audits.
- Establish a strong liaison with individuals from other teams and work collaboratively, including establishing relationship with UK Quality department.
- BSc in biological sciences or related field.
- 5+ years experience working within GMP compliant Quality Department in commercial biotech or biologics environment.
- Knowledge in GMP in relation to EU, FDA, MHRA and/or ICH- standards.
- Independent, with strong communication and organisation skills.
- Knowledge and experience using Quality Management System.
- Comfortable working in a fast-paced environment
If this role interests you, then please apply now. You can submit your CV and cover letter highlighting your expertise as a Senior Quality Assurance Associate. Successful candidates will be contacted in the next 48 hours and be processed through the 3-stage hiring process highlighted below.
Stage 1: Screening call with Life Science People representative.
Stage 2: Telephone interview with hiring manager.
Stage 3: Technical assessment with Quality Control laboratory manager.
Further details will be disclosed on application and the process should take no longer than two weeks.