GCP QA Associate

Quotient Sciences

Posted on: September 23, 2022

Closing: October 23, 2022

Salary: Undisclosed

Position Type: Full Time

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.

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 of efficient and effective Quality Assurance (QA) systems for clinical and scientific research studies
  • To comply & adhere to GCP guidelines and regulations as required of this role.

Main tasks and responsibilities will include:

  • Ensure efficient and effective execution of QA systems in accordance with proceduralized requirements.
  • Support the collection and analysis of quality metrics and lead initiatives to improve performance to target.
  • Serve as a QA resource to provide input and guidance to cross function teams on quality issues, CAPAs, vendor management, sponsor audits, serious breaches, internal audits including study compliance audits, change controls, file notes, GCP questionnaires and other compliance issues.  Conduct peer review of documentation, as necessary.
  • Help develop key quality indicators and analyse data and facts to identify and solve problems.
  • Act a

Quotient Sciences

Posted on: September 23, 2022

Closing: October 23, 2022

Salary($): Undisclosed

Position Type: Full Time

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