Job Description:

• The Global Product Quality Specialist will be responsible for managing (and owning as needed) documentation and change controls associated with key deliverables to clinical and commercial documentation across multiple programs.

• Functional responsibilities include tracking of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines.

• Support Change control, Deviation and CAPA management, and author and/or review GxP documents as required.

• Support the revision and/or review of Specifications, Protocols, Annual Product Quality Review (APQR) templates and documents as required.

• Support GxP document management in electronic documentation systems (e.g., Veeva etc.).

• Provide assistance to other Global Product Quality staff members as needed. Performs other QA duties as assigned.

Basic Qualifications:

• Minimum of 3 plus years working under GMP conditions. BA or BS degree.

• Strong written, verbal, and organizational skills, and ability to work in interdisciplinary and cross-functional teams.

• Experience with Infinity, eQRMS, electronic documentation systems (Veeva), and other quality systems is preferred.

• Experience with owning change controls is required.

• Scientific background with basic understanding of analytical methods, stability, specifications and Quality Control

• Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.

• Detail oriented with a high degree of focus. Able to follow instructions and procedures, both written and verbal.

• Able to understand complex work practices.

• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.

• Able to perform with minimal supervision and contribute in a team environment.

• Basic knowledge and ability in using Microsoft Office Package.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.