Quality Assurance Specialist/ GCP Details

Quality Assurance Specialist/ GCP

Spark Therapeutics - Philadelphia, PA

Employment Type : Full-Time

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

We don’t follow footsteps. We create the path.

Summary

This is an entry level role that will be responsible for supporting administrative and operational GCP and GVP audit and compliance activities under guidance and supervision of the Clinical Quality Assurance GCP Lead (and/or designee).

This role is meant to prepare/ train an individual to take on a CQA auditor role.

Responsibilities

% of Time Job Function and Description

75% Perform operational tasks in support of CQA activities:

• Work with CQA Management to develop CQA business reports, as applicable
• Support CQA auditors, as needed (i.e. preparation, conduct, follow-up)
• Support CAPA activities
• Support the development, maintenance, and/or continuous improvement of Global CQA Quality System (SOPs, work instructions, tools, templates, etc.).
• Support applicable Clinical Development, Pharmacovigilance and non-clinical SOP development, training and administration
• Support the development and tracking of compliance metrics
• Other duties, as assigned

25% Perform administrative tasks in support of CQA activities:

• Track and follow-up, as appropriate, on CQA audits and reports through the audit reporting lifecycle (i.e. planned audits to audit closure)
• Maintain CQA Central Files/ electronic repositories
• Organize Trainings on behalf of CQA
  

Requirements

Minimum: University degree in Scientific Discipline/ Life Sciences or related disciplines

Minimum of 1 year of pharmaceutical industry experience and/or clinical research experience

Competencies

• Basic knowledge of GXPs, GCP/ GVP experience preferred.
• Very good prioritization, organizational, communication, and negotiating skills
• Very good written and verbal communication skills in English
• Good computer skills
• Willingness to learn