Quality Officer

**JOB OVERVIEW**

**Job Title **Quality Officer

**Department **Quality

**Reports to **Quality Manager

**ANTIBODY ANALYTICS - WHO WE ARE**

We are an innovative and vibrant biotechnology company. We believe that scientists deserve the best data and patients deserve the best drugs, so our mission is to provide our drug development partners with data of outstanding quality which gives them confidence to expedite new healthcare solutions to market. We began in 2015 and through our expertise, technology, and amazing employees we have grown to where we are today, and we plan to keep on growing. We’re not all scientists and academics, we are a diverse, talented, and fun team who enjoy the occasional pizza Friday, but what’s at the core of what we do is our culture and values - that’s what makes us proud and stand out.

**THE ROLE**

As Quality Officer you will take all the skills, learning, knowledge, and experience gained from previous experience or as a Junior Quality Officer 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, deviations, and CAPAs.
You will have responsibility for performing real-time audits of live lab documentation and ad-hoc study audits and providing feedback on your findings to the owners of the reviewed documentation. You will also have responsibility for ensuring that the
Quality team undertakes and delivers the internal audit schedule on time which includes circulating a summary of the audit findings to the Quality Manager.
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.

**WHAT WE EXPECT YOU TO DO**

**QMS**
- Actively engage with Operations team to ensure that the Company are being compliant in the performance of customer projects. This will be achieved through performing audits and reporting any non-compliances.
- Monitor the status of change controls, deviations, CAPAs and risk assessments and provide support to the record owner to aid completion and compliance.
- Perform data checks from customer studies if required to assist Operations to meet customer deadlines.
- Perform internal audits as listed in the internal audit schedule and report trends to the Quality Manager.

**Equipment/Facilities**
- Support junior colleagues in the review of scheduled maintenance tasks in LIMS to ensure master schedule is up to date.
- Provide support to our Operational Support colleagues by approving documentation provided by external contractors for maintenance activities.
- Review Installation and scheduled Operational/Performance Qualification documentation for compliance against our QMS.

**Samples**
- Train and guide Junior Quality Officers in the review, release, and movement of shipments of customer samples and provide additional practical support when necessary.
- Support the Junior Quality Officers in resolving any unforeseen issues with sample shipments.
- 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.

**WHAT WE EXPECT YOU TO DO**

**Training**
- Deliver quality induction training to all new employees as defined by the Quality Manager.
- Develop and deliver training on, change management, management of deviations, CAPAs and risk assessments to colleagues who have been nominated for this training which is run regularly throughout the year.
- Deliver training in performing audits and material/sample management to junior colleagues within the Quality Department.

**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.

**WHAT WE ARE LOOKING FOR FROM YOU**

We would like you to have the following:

- Have good knowledge of GMP/ISO13485/ISO9001.
- Have experience of working in a Quality role within a CRO/CTO or life science company.
- Be able to demonstrate good IT, writing and presentation skills.
- 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.

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

- Able to prioritise day to day work without supervision.
- Highly organised, be productive with the ability to deliver your work on time and to a high standard.
- Friendly with a helpful attitud