Quality Systems Associate
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 1,300 talented individuals globally, located at state-of-the-art development, manufacturing, clinical and data sciences 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.
We have an exciting opportunity for a Quality Systems Associate to join our QA department in Nottingham. This will be on a permanent basis. The successful applicant will be responsible for overseeing the site’s Quality Management System and assuring its continued compliance with applicable global regulations, standards, global and local company policies and procedures. 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:
- Administer the site’s CAPA, change control, internal audit, and document control systems.
- Support the company’s eQMS system, including the Helpdesk.
- Ensure all quality documentation is created, reviewed, approved, and retained in accordance with established procedures and regulatory requirements.
- Interpretation and communication of information (e.g. GXP requirements) and provision of advice on quality issues to colleagues throughout the organisation.
- Support the GXP training program at the site to assure training is comprehensive, appropriate and drives the required quality competencies.
- Deliver quality systems and GXP training for all site personnel and ensures that training is adequate and available.
- Co-ordination of the company archiving programme (paper and electronic) in line with defined policies and procedures and digital preservation strategy, as agreed stake holders.
- Provision of archiving guidance, training and expertise to operational colleagues.
- Identify and deploy effective quality controls to assure data integrity within and across quality data sources.
- Collection, tracking and trending of quality metrics.
- Identify compliance gaps and adverse trends in quality systems and escalate events requiring immediate action to management.
- Involvement in regulatory inspections as required.
- Performance of other duties as reasonably required.
We are looking for a Quality Systems Associate who will thrive in a fast-paced working environment, with the ability to multiple tasks simultaneously.
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 in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
Skills and experience required:
- Science-based HND or degree
- Minimum of 2 years’ experience in the pharmaceutical industry or similar regulated environment
- Experience and knowledge of Good Manufacturing Practice and/ or Good Clinical Practice or Quality management system requirements in a similar regulated environment.
- Strong interpersonal skills
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.