Vacancies

Formulation Data Reviewer

Job Title:Formulation Data Reviewer
Reference:QUO01718
Location UK ~ Nottingham
Type: Permanent

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

Due to business growth, we have a brand-new career opportunity for a Formulation Data Reviewer at our site in Nottingham. You will join the Formulation Development team and be responsible for assuring the quality of laboratory write-ups, executed Batch Manufacture Records (BMRs) and transcription check reports as specified in Standard Operating Procedures.

Main tasks and responsibilities:

Review in-process, final product, characterization results for accuracy and completeness.
Ensure that the work performed is compliant with applicable procedures, methods, and specifications.
Ensures that all affiliated data including electronic data and respective Process Methodology Document (PMD) and BMRs are complete and reviewed.
Review documentation for accuracy in data reporting/transcription and the correct entries of all associated references
Discuss with formulation scientists when necessary to resolve all required corrections to paperwork.
Communicate frequently with Management to keep them informed of potential delays in data review as well as the reasons why the delay is occurring.
Consult with Management regarding priority of assignments. Provide immediate notification to Management of any deviations/discrepancies noted during the review process.
Provide feedback and suggest ideas to Management to improve the review process.
Perform any other duties as assigned by the management.
If required, scan the approved write-ups, PMD and/or BMRs to the respective electronic study folders for future reference.

The candidate:

The successful candidate will have a degree in pharmaceutical sciences, or a life science subject or the equivalent combination of education and related experience will be considered. The following experience is required for this role:

Previous experience in a GMP pharmaceutical laboratory or equivalent, including experience in development, manufacturing, and characterization of pharmaceutical drug products
Experience of authoring, reviewing and approving manufacturing and documentation (such as laboratory write-ups, Batch Manufacturing Records)
Experience in archiving and reconciliation activities
Experience preparing cGMP and other laboratory documents
Excellent organizational skills and attention to detail.
Effective communication both verbally and written
Proficient in Microsoft Word, Excel, and PowerPoint

Other skills required:

Ability to work to strict and tight deadlines
Able to juggle a range of tasks simultaneously
Confident working in a fast-paced work environment with flexibility to respond to client demands

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.

We are open to considering candidates wanting part-time or full-time.

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.