QA Associate

QA Associate Nottingham, England

Quotient Sciences
Full Time Nottingham, England 38701 - 65494 GBP ANNUAL Today
Job description

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 QA Associate (supplier management) to join our QA department in Nottingham. This is a full-time role, however other working arrangements will be considered. The role requires an on-site presence. The successful applicant will be responsible for the service approvals of all GxP providers utilised 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:

  • Utilising a standardised approach to the initial qualification procedures of our variable supplier base, ensuring that targeted and clear questions are utilised to solicit comprehensive responses. Building a repository of this information.
  • Ensuring a standardised approach is in place in respect of documentation supporting the supplier accounts e.g. Quality agreements
  • Maintenance of a centralised supplier repository
  • Performing supplier assessments and assisting with supplier audits, where applicable, covering a wide range of suppliers and subcontractors such as clinical laboratories, raw material manufacturers, software suppliers.
  • Representing QA in the change control process for any changes associated with our suppliers. Ensuring changes to processes, systems, equipment and facilities are appropriately assessed and implemented
  • Deviation/CAPA management for any issues relating to third parties.
  • Challenging quality through internal process flow reviews to drive continuous improvement in the way that we work with our suppliers.
  • Collection, tracking and trending of supplier quality metrics.
  • Providing cover for other team members as appropriate.
  • Involvement in Sponsor audits and/or regulatory inspections as required
  • Performance of other duties as reasonably required

The Candidate

We are looking for a QA Associate (Supplier Management) 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
  • Having to juggle a range of tasks/issues simultaneously
  • Working outside normal working hours
  • Needing to respond to client demands
  • Travel to vendor sites for auditing purposes

Skills and experience required:

  • Educated to at least Degree level, preferably in Life Sciences
  • Experience and knowledge of Good Manufacturing Practice and/ or Good Clinical Practice or supplier management experience in a similar regulated environment.
  • Competent in the use of Microsoft Office packages including Word, Excel & PowerPoint.

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.

QA Associate
Quotient Sciences

www.quotientsciences.com
Nottingham, United Kingdom
Mark Egerton
$25 to $50 million (USD)
501 to 1000 Employees
Company - Private
Biotech & Pharmaceuticals
1990
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