Location: New York, NY
Duration: 6+ months
Job Responsibilities:
Resource needed to own multiple QA System activities (Change Control, QE/CAPA, Product Complaints, etc.) during reconfiguration/re-engineering of Quality Systems as well as continuous improvement activities. Will be getting own laptop.
POSITION SUMMARY:
- This position is responsible for maintaining and improving Intercepts Quality Management Systems with respect to Product Quality Complaints, Deviations, QEs/CAPAs, Change Controls and Document Management.
- This role will report directly to the Associate Director of Quality Systems in NY and has visibility to Sr/Executive leadership.
- The role itself is holistic in nature and knowledge about all aspects of Quality Systems and their interactions with various GxPs is expected.
ESSENTIAL FUNCTIONS:
- Liaise with Intercept QA and other departments to maintain compliance to the Intercept Quality Systems, specifically: Oversee Change Control process through the entire change life cycle.
- Aid in review and completion of product quality complaints. o Facilitate Quality Event and CAPA review sessions, actively follow up on overdue deviations.
- Assist Document Management in day-to-day activities. (e.g., user access management, closure of tasks, etc.).
- Preparation of quality trend/metrics (for QE/CAPA, Doc Control, Complaints and Change Controls).
- Other duties as assigned.
- Experience / knowledge of in the following: GxPs - GCP, GMP and GDP Quality Systems appropriate for late phase Clinical Development and Commercial Drug Product. o Applicable CFR, ICH, EU, and GxP regulations.
- Skills in the following areas: Must be able to take initiative, work independently and prioritize workload.
- Good, collaborative interpersonal skills, positive attitude, and problem-solving capabilities.
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills. o Attention to detail is a must.
- Proficient in the following areas and computer applications: Master Control, Veeva Quality Docs or similar.
- SharePoint / Power BI o Microsoft Office Suite (Excel, PowerPoint and Word).
- Minimum requirements: o BSc/BA in Organic Chemistry, Biochemistry, Applied Biology, Pharmacology or a relevant science or 5 years of pharmaceutical drug QA experience, specifically in quality system operations.
- Fluent in English, both spoken and written.
Company:Integrated Resources, IncLocation:New York - United StatesJob Types:ContractPost Date:October 28, 2021Valid Through:November 27, 2021