EH16, Gilmerton, City of Edinburgh
Based at the Edinburgh BioQuarter, RoslinCT is a leading Contract Manufacturing and Development organisation within the cellular therapies/ATMPs field, performing cutting edge investigational medicinal product manufacture for clinical trials across Europe and the US.
The Company is now embarking on an exciting period of planned growth, and we are recruiting for some key operational roles to help support and lead that growth into the future, including this one.
We are searching for a Quality Control (QC) Analyst II - Analytical to join our expanding team and provide support for our analytical QC activities in support of the company’s cGMP manufacture of cell therapies.
Candidates for this role must also be able to demonstrate a strong commitment to our Core Values, and so should be:
* Passionate about Customer Satisfaction
* Able to support a ‘one team’ approach
* A great communicator
* Committed to personal growth and development
* Accountable for their work
This role of QC Analyst II - Analytical will report directly to the Senior QC Analytical Analyst and the Assistant QC Manager and will provide support for QC activities including assay work, assay-related GMP paperwork, assay validation, arranging testing with external test houses, writing and updating of controlled documents and timely completion of QMS documentation.
Your responsibilities as the QC Analyst II – Analytical may vary but will include;
* Performing QC activities and maintaining records in accordance with cGMP.
* Training QC Technicians, QC Analyst I and other members of staff in analytical techniques.
* Validation of new QC assays and technical transfer of client assays
* Assessment of new equipment and methods.
* Preparation of QC study/experiment protocols and writing of reports
* QC checking CoAs for externally contracted work.
* Maintenance of the QMS by writing incident reports, change controls, CAPAs and deviations.
* Write and update SOPs for QC activities, and compile QC reports and certificates of analysis in addition to more general record keeping.
* Participation in process improvement activities.
* Support the compilation of information used to communicate with clients.
* Communicate procedures and results with clients and liaise with external suppliers, demonstrating excellent customer service skills for both internal and external customers.
* Compliance with all Health and Safety policies and procedures.
* Providing out of hours cover for critical equipment alarms as required on a rotational basis.
The post holder will have;
* A BSc in a relevant Life Sciences discipline
The ideal candidate will also have:
* Applied knowledge of analytical techniques gained from working within a GMP scientific laboratory.
* Experience in flow cytometry, tissue culture or molecular biology – desirable.
* Group Personal Pension Plan: 3% Employee contribution with an Employer contribution of initially 5% for the first year of joining the scheme then a 1% increase per year until a maximum of 8% is reached.
* Group Life Cover, 3X Salary
* Health4All Cash Plan where you are able to claim cash back towards dental check-ups and treatment, new glasses, contact lenses and therapy treatments such as physiotherapy and chiropody and more.
* Employee Assistance Programme
* 31 days annual leave with an extra day from 3 years’ service and a further day from 5 years’ service.
* 4 public holidays
Location: Edinburgh BioQuarter. Please ensure you can commute to our site before applying