Company: Integrated Resources
Posted on: March 16, 2023
Title: QA Associate
Location: Morristown, NJ
Duration: 6+ Months
This position is responsible for maintaining and improving Client s 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.
Liaise with Client s QA and other departments to maintain compliance to the Client s Quality Systems, specifically:
Oversee Change Control process through the entire change life cycle. o Aid in review and completion of product quality complaints.
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.
Required Knowledge and Abilities:
Experience / knowledge of in the following:
GxPs - GCP, GMP and GDP Quality Systems appropriate for late phase Clinical Development and Commercial Drug Product.
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 o Strong verbal and written communication skills are essential.
Excellent organization and multi-tasking skills.
Attention to detail is a must.
Proficient in the following areas and computer applications:
Master Control, Veeva Quality Docs or similar o SharePoint / Power BI
Microsoft Office Suite (Excel, PowerPoint and Word)
BSc/BA in Organic Chemistry, Biochemistry, Applied Biology, Pharmacology or a relevant science
5 years of pharmaceutical drug QA experience, specifically in quality system operations.
Title: QA Associate
Keywords: Integrated Resources, Newark , QA Associate, Other , Morristown, New Jersey
here to apply!