THE ROLE

As Quality Specialist you will take all the skills, learning, knowledge from previous experience to the next level. You will gain a greater technical understanding of our QMS with regards to Material Management, Sample and Equipment Management. More importantly, you will be a key player in the approval of change controls, risk assessments, unplanned events and effectiveness checks for CAPAs.

You will have responsibility for performing real-time audits of live lab documentation and process audits and ensuring the internal audit schedule is met.

You will promote the company values and the Quality Departments mission to “get everyone doing the right thing even when no-one is watching” through your actions and by training-out key aspects of the QMS companywide with particular focus on meeting the requirements of ISO 9001: 2015.

WHAT WE EXPECT YOU TO DO

Key responsibilities:

QMS

· You will actively engage with the Operations, Commercial, and CTD teams to ensure that the Company are being compliant in the performance of customer projects and in meeting the requirements of ISO 9001: 2015. This will be achieved through performing reviews, supporting unplanned events and projects, audits and reporting any non-compliances.

· You will monitor and provide support to colleagues to allow completion of change controls, unplanned events, CAPA effectiveness checks and risk assessments which meet the requirements of ISO 9001.

· Perform internal audits as per the internal audit schedule and report trends to the Quality Manager, ASDs and Department Heads.

· Support projects involving computer systems validation and data integrity.

Materials/Cell Banks

· You will actively engage with the Operations team to ensure that the Company are being compliant with the QMS and ISO 9001 in respect to receipt, release, use and disposal of materials. This will be achieved through performing review of parent specifications, taking responsibility for supplier qualification and monitoring, and review and reporting any non-compliances.

Equipment

· You will be responsible for the Quality review of IQ/OQ/PQ documentation for data generating equipment (DGE).

· Review and approve draft FSOPs raised (new or in change control).

Customer Samples

· Review and release customer sample shipments and provide additional practical support to Operations when necessary.

· Co-ordinate with Study Managers and Operational Support on the return or discard of samples and manage the update of LIMS when a study is completed.

Training

· Deliver quality induction training to all new employees as defined by the Quality Manager.

· Develop and deliver training on, change management, management of unplanned events, effectiveness checks and risk assessments to colleagues who have been nominated for this training which is run regularly throughout the year.

· Deliver annual GDocP training to the entire company.

Process Improvements

· Be involved and participate in any process improvement projects you are asked to lead and/or join.

Health and Safety

· Understand and ensure compliance of COSHH documentation in support of correct handling and storage of equipment, materials, and samples.

· When directed by the Health and Safety Committee, undertake Health and Safety Risk Assessments across the business.

General:

· You will take responsibility to help identify projects and required training to enhance your own learning and ongoing development.

You will identify areas for improvement within the Quality team’s processes and implement agreed plan to rectify shortfalls or drive improvement.

WHAT WE ARE LOOKING FOR FROM YOU

We would like you to have the following qualifications:

· A graduate in a Life Science subject.

· Have good knowledge of ISO 9001: 2015.

· Be able to communicate complex issues in an open and supportive manner.

· Have experience in managing quality records within a LIMS or QMS system such as Q-Pulse.

· Proficiency in MS Office, Teams and other relevant software as appropriate, with an aptitude to learn how to use new software to record, track and communicate to the wider organisation in real time and/or when requested.

To support a culture within RoukenBio which is aligned to our company values and behaviours, we would like you to be:

· Focused, with an exceptional attention for detail.

· Self-motivated, highly organised, multi-tasker who can work independently.

· Approachable and supportive, able to work alongside and with a range of colleagues.

· Goal-oriented, able to deliver success for both self and the wider team within required timescales.

· Customer focused with our customers at the heart of everything that you do, particularly in understanding the needs and requirements of our customers.

· Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously.
- Possess or have the ability and willingness to quickly assimilate an up-to-date understanding of the drug development process, particularly as it relates to biologics, cell and gene therapies to help you put your role into context and why it makes such an impact.

· A creative thinker who is adaptable to change to achieve the company’s strategy even with shifting priorities.

· An excellent communicator (verbal and written) who can foster relationships externally and internally at all levels within the business.

A champion of self-learning and sharing best practice with colleagues in support of employee development. Enthusiastic to learn and immerse yourself in the company to understand the business, our vision and our goals.

WHAT YOU’LL GET FROM US

You will get the chance to learn, grow, develop, and enhance your career within a biotechnology company at the forefront of drug development strategies. In addition, the company offers the following benefits package:

• Starting salary of £25,235 which is linked to performance related pay.

• Pension.

• 32 days holiday per annum (inclusive of public holidays) which increases to a maximum of 37.

• Death in Benefit Service which includes access to a 24/7 virtual GP.

• Flexible working.

• Refer a Friend Scheme.

• On-site car parking.

• Free Healthy Snacks.

• Merit Award Recognition Scheme.

• The opportunity to join several committees or focus groups (Employee Engagement, Wellness, Recognition, Health & Safety or Social Committee).