QA Associate (Hybrid)

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

• Ensuring operations are compliant with internal procedures and regulatory requirements
• · Supporting the provision and development off efficient and effective Quality Management System
• · Work effectively with colleagues across all functional areas to achieve objectives while maintaining good working relationships.
• · Give information in a clear, concise and timely manner and often use negotiation and consultation skills to resolve complex issues.
• · Coordinating the review of documentation in support of manufacturing activities and the QA project teams.
• · To comply & adhere to GXP guidelines and regulations as required of this role.
• · Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.

Main tasks and responsibilities will include:

• Review and provide feedback on testing CoAs, stability study documents, risk assessments, product specifications, executed/master batch records, and SOPs.
• Support QA Specialists in tech transfer activities to support customer registration, scale up, validation and commercialization readiness.
• Provide QA support and oversight to the production of registration batches and commercial product material to ensure that product is manufactured in accordance with specifications, our customer’s market authorizations and GMP requirements.
• Provide guidance to manufacturing and laboratory personnel to proactively ensure GMP compliance.
• Support and provide input to QA Specialists for their product release. As required, work to resolve identified issues to support timely release of product that conforms to specifications.
• Participate in investigations related to deviations, out-of-specifications or atypical results, and customer complaints. Identify and implement corrective and preventive actions that mitigate potential for issue recurrence.
• Communicate quality-related information and data to key stakeholders within and outside of QA.
• Assist in the planning and execution of customer audits. As required, support the compilation of responses to customer audit findings to assure they are submitted to customers on time.
• Assist in regulatory inspections to ensure successful results.
• Participation in the change control process to ensure changes to processes and systems are managed appropriately to maintain GCP Compliance
• Provide work product that meets the highest quality standards by ensuring work is accurate and delivered in accordance with established timelines. Keep the QA Specialists informed on the status of customer-specific activities

 

The Candidate

• Bachelor’s Degree in Science, or an equivalent amount of education and experience
• Minimum two (2) years’ related experience in QA/QC or life sciences
• Good understanding of CGMP requirements
• Good organization and time management skills
• Effective written and oral communication skills
• Good interpersonal skills with a special focus on customer satisfaction.
• Experience working with Good Manufacturing Practices (GMP).

 

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.

If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at careers@quotientsciences.com.