Gcp QA Associate

2 weeks ago

Nottingham, United Kingdom Quotient Sciences Full time

**Company Overview**

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.

People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

**The Role**

We have an exciting opportunity for a GCP QA Associate to join our QA department in Nottingham. This is a full-time role, however other working arrangements will be considered. The successful applicant will be responsible for all supporting all aspects of GCP QA, including Phase 1 accreditation, and the site’s Quality Management Systems to assure continued compliance with all UK and global regulations, standards, global and local company policies and procedures at the Nottingham site. You will be required to comply and adhere to GXP guidelines and regulations as required of this role whilst working effectively with colleagues across all functional areas to achieve objectives whilst maintaining good working relationships.

**Other responsibilities will include**:

- Performing internal audits to monitor compliance with the QMS, Good Clinical Practice (GCP) and Phase I Accreditation requirements
- Assessment of external suppliers and subcontractors via audit or questionnaire
- Hosting customer audits of Quotient
- Support and guide the completion of Quality Issue investigations to ensure robust root-cause investigation and targeted CAPA
- Ensuring CAPAs raised are SMART, targeted and effective.
- Participation in the change control process to ensure changes to processes and systems are managed appropriately to maintain GCP compliance
- Review and approval of clinical equipment specifications
- Deliver GCP training across the business
- Review of Clinical Study Reports
- Writing, reviewing and approving SOPs
- Management of blinded materials
- Involvement in regulatory inspections as required
- Working with the Quality System & Compliance team to ensure the quality system develops and is inclusive of GCP requirements and best practice (where appropriate).
- Working with the Validation team to ensure all projects are progressed through to implementation in a compliant manner
- Review of study sprecific file notes for appropriate categorisation, detail and impact assessment. Trending of deviation file notes.

We are looking for a GCP QA Associate who will thrive in a fast-paced working environment, with the ability to multiple tasks simultaneously.

**Job Demands**

The job may involve the following:

- Very high concentration of work
- Strict and tight deadlines
- Working in a hazardous environment with high requirement to follow safety procedures
- Having to juggle a range of tasks/issues simultaneously
- Working outside normal working hours
- Needing to respond to client demands

**Skills and experience required**:

- Minimum of 3 years Quality experience
- Experience working with Good Clinical Practice (GCP) or other quality management system disciplines
- Life Science degree
- Proven ability to work autonomously, to seek answers and self-motivate
- Proven ability to adapt both communication styles and formats, to ensure a consistent, clear message
- Proven ability to work within a team, to promote an atmosphere of respect, support and continual learning

**Company Benefits**

In return you will receive a competitive salary, a generous benefits package, excellent training, and development, as well as an exciting career within a fast paced and dynamic business.

**Our Commitment to Diversity & Inclusion**

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.

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