QA Administrator

**A Career with Purpose**

Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world. We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.

**About the Role**

We are looking for a Quality Assurance Administrator to join the Clinical Development team. Their purpose is to provide general administrative, clerical and organisational support to the Bionical Emas Quality Assurance (QA) Function, with a particular focus on supporting the areas of non-compliance management and auditing/inspections. This role also assumes primary responsibility for the coordination of QA meetings and administration of the electronic Learning Management System (eLMS). We will need this individual to be able to commute to the Letchworth office a couple times a month.

**What will your job look like?**
- Organise Quality Assurance Oversight Committee (QAOC) meetings, including scheduling, agenda / report collation & dissemination, minute-taking, action tracking, filing
- Produce QA Key Performance Indicator (KPI) / metrics reports
- Provide administrative support for other meetings, as required
- Administer the electronic Learning Management System (eLMS), including allocating users, producing compliance reports, providing support to wider Bionical Emas staff
- Contribute to, and support the QA Officer in, the administration of controlled documents (policies, standard operating procedures, etc.) within the Document Management System (DMS) and the administration of training within the Training Management System (TMS)
- Provide clerical and administrative support in the management of Quality Event (QE) and Corrective Actions & Preventative Actions (CAPA), including tracking deadlines, liaising with QE/CAPA Owners, and collating & circulating reports
- Provide clerical and administrative support for the hosting of Client audits & Regulatory Authority inspections of Bionical Emas, including tracking upcoming audits/inspections, supporting with documentation requests, scheduling meetings, booking rooms and lunches, tracking findings, responses and CAPA
- Provide clerical and administrative support in the management of vendor/supplier qualification, including tracking and documentation filing
- Provide clerical and administrative support for Bionical Emas’ performance of internal audits and audits of vendors/suppliers, including tracking, scheduling meetings, and tracking findings / responses / CAPA
- Contribute to the ongoing maintenance and development of the electronic Quality Management System (eQMS) and its core modules
- Identify gaps in processes and facilitates the changes required in process improvements
- Provide general administrative support to the QA Function as required
- Perform any other reasonable task as approved by the Line Manager

**What will you need to succeed?**
- GCSE (incl. Maths and English) or higher educational standard is essentialExcellent attention to detail and ability to work accurately in a busy and demanding environment
- Strong organisational skills; ability to prioritise, with good time management skills
- Credible and confident written and verbal communicator
- IT literate with ability to work with commonly used IT platforms and packages Hands-on approach, with a ‘can do’ attitude
- Strong analytical and problem-solving ability
- Prior experience within the industry would be advantageous but not a must

**What will you get in return?**

We want you to do your best work We care about our people’s well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.
- 25 days of vacation
- Vacation days purchasing scheme
- 1 extra vacation day per each 3 years of service
- Discretionary Annual Bonus
- Sabbatical of 3 to 6 months (after 2 years of service)
- Free food and beverages at all offices
- Life Insurance
- Health Insurance and Employee Assistance Programme
- Employee Support Networks - help us continue to build on our inclusive culture
- Flexible and hybrid work

**Does this sound like you?**
- It is time to apply, and we can’t wait to hear from you_

Even if you don't meet 100% of the requirem