QA Associate

Company: Integrated Resources
Location: Morristown
Posted on: March 16, 2023

Job Description:

Title: QA Associate

Location: Morristown, NJ

Duration: 6+ Months

Responsibilities:

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.

Essential Functions:

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)

Qualifications:

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.

Keywords: Integrated Resources, Newark , QA Associate, Other , Morristown, New Jersey