Vacancies

QA Associate Coordinator

Job Title:QA Associate Coordinator
Reference:QA-21-209-1
Location US ~ Boothwyn, PA
Type: Full Time

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 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

The QA Associate will support contract of clinical and commercial manufacturing for Pharmaceutical products. The QA Associate will support the technology transfer for clinical and commercial manufacturing and provide QA oversight of the manufacturing process. They will ensure the implementation and maintenance of an efficient and effective quality management system, maintain open and timely communication across the teams, and visibly demonstrate the behaviors necessary to maintain compliant GMP practices and advance the quality culture. 

Main tasks and responsibilities

  • Ensure efficient operation of the team and increasing visibility of activities by providing administration duties where required.
  • Support/conduct internal audits to monitor compliance with the QMS and with Good Clinical Practice (GCP).
  • Co-ordination, guidance and review of quality issue investigations and CAPAs
  • Involvement in regulatory inspections as required
  • Support in SOP lifecycle management where required
  • Supporting the collation of Quality metrics
  • Participation in the change control process to ensure changes to processes and systems are managed appropriately to maintain GCP Compliance
  • Support the hosting of customer audits of Quotient
  • Development and continual improvement of the company quality system as required
  • Provision of Quality training in line with Quotient defined standard

 

The Candidate

  • Associate degree in a scientific field, or equivalent experience
  • Minimum two (2) years’ related experience in QA or QC in 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.

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.