GQAA - 2019
US ~ Miami
GCP QA Associate
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
- 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
Main tasks and responsibilities:
- 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 as QA representative to clients, program and project teams
- Perform audits to monitor compliance of internal operations with internal procedures and regulatory requirements (GCP), including;
- Documentation such as clinical protocols and reports
- Facility audits
- Process audits/ inspections
- Provide guidance on corrective and preventive actions to address audit findings.
- Perform vendor audits and assessments covering a wide range of suppliers and subcontractors that provide clinical laboratory testing services, clinical trial material, IT services, and other GCP related products and services.
- Develop, implement, and maintain the site’s quality system. Author, review and approve SOPs and assure compliance with current regulatory requirements. Assure documents are issued, controlled and archived in accordance with company procedures.
- Participate in the change control process to ensure changes to processes, systems, equipment and facilities are appropriately assessed and implemented after proper verification of changes.
- Host sponsor audits, co-ordination responses and follow up of corrective and preventative actions.
- Interpret and communicate regulatory requirements and expectations and provide guidance to members of staff and customers.
- Participate in investigations of quality issues. Assure that root cause(s) are identified and effective corrective actions are implemented in a timely manner to mitigate recurrence of issues. Involvement in regulatory inspections as required.
- Provide GCP training and other training as required for new and existing employees.
- Perform other duties as required.
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
- Bachelor’s Degree in a scientific field, or Associates Degree with equivalent experience
- Minimum 3 years relevant experience in life sciences quality
- Effective written and oral communication skills
- Knowledge of the complete regulatory framework around clinical trials
- A good understanding of Good Clinical Practice (GCP)
- Experience of conducting internal audits against company procedures and regulatory requirements
- Detail oriented with excellent problem solving and organizational skills.
- Ability to perform multiple tasks and prioritize work to assure business and compliance objectives are met
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.