Analytical Technical Writer

Job description
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.

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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

Summary Of Job Purpose
• Author and review, DS, 14C DS, DP and 14C DP and associated intermediate specifications for Alnwick site.
• To be conversant with and ensure compliance with quality requirements for Quotient’s finished products.
• Comply and adhere to GMP guidelines and regulations as required of this role.

Main Tasks And Responsibilities
• Act as Technical Writer for designated projects:
• Author and review DS, 14C DS, DP and 14C DP and associated intermediate specifications for Alnick site
• Collate information, from / QC / chemistry / QA / Production and the Sponsor/ Regulatory to create the specifications.
• Hold specification meetings with relevant personnel.
• Author the specification.
• Manage the specification workflow in Veeva.
• Ensure timely delivery of the specifications to meet project timelines.
• Collaborate with internal team to ensure timely reviews / approvals.
• Collaborate with PM to ensure Sponsor reviews, to ensure timely reviews and approvals.
• Ensure the quality of specifications in line with current quality requirements and risk assessments and regulatory guidelines.
• Assist in resolving issues to ensure relevant approvals are achieved;
• Ensure QC processes to assure the quality of the specifications are conducted;
• Maintain the SOP and associated forms for specifications at Alnwick.

Additional Tasks/responsibilities
• Perform other duties as reasonably required.

Qualifications And Experience Required For Competent Performance
• Educated to a minimum degree level in a chemistry / Biology/ Pharmacy scientific discipline or with relevant work experience in pharmaceutical industry.
• Possession of scientific and technical background.
• Possession of analytical thinking and problem solving abilities.
• Proven ability to work effectively independantly and also in a team.
• Experience of technical writing and use of word and excel.

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, ****** orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.