Senior QA Specialist - Clinical
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.
- To provide QA oversight for all GMP activities performed to support the manufacturing, packaging, and testing of pharmaceutical products at the pre commercial development phase.
- 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
- To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- QA Specialist will review and approve Quality-related documents, including but not limited to: component and drug product specifications, analytical qualification/ validation reports, stability protocols and reports, master batch records for manufacturing and packaging of clinical trial materials and registration batches, and associated executed batch records.
- Review, provide feedback on, and author Standard Operating Procedures.
- Inspect and release manufacturing rooms and equipment for use in manufacturing clinical batches.
- Review, provide feedback on, author, and approve (as appropriate) Quality Incident reports such as product complaints, laboratory investigations, deviations, change controls, CAPAs, and investigations.
- Attend Quotient Sciences project team meetings as appropriate
- Conduct GMP training when needed and as appropriate
- Provide support for client audits and regulatory inspections
- Provide information on quality metrics upon request
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
- B.S. degree in a scientific field, e.g., chemistry, pharmaceutical science, engineering
- At least five (5) years related pharmaceutical industry experience desired
- M.S. degree in a scientific field preferred
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 email@example.com.