Compliance and Quality Assurance Professional

5 days ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Overview

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey. We are committed to delivering exceptional service to our clients while providing our candidates with unparalleled opportunities. As a Quality Assurance Compliance Specialist, you will play a vital role in ensuring the highest standards of quality and compliance within these industries.

Key Responsibilities:
* Perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures
* Document management, investigations, CAPA, SOPs, qualification and validation reports, QC data
* Support quality management with various department, organizational, and operational excellence initiatives
* Exercise independent judgment within generally defined practices and policies
* Support internal and external audits, including interaction with Health Authorities and clients

Requirements:
* BS biological sciences or other relevant field of study
* 5 years' + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred
* Experience in authoring, reviewing, and/or approving cGMP/cGTP-related documents required
* Understanding of quality system applications, including electronic applications for training, deviations, CAPA management, etc.
* Familiarity with FDA, ISO, and other regulatory agency guidelines
* Working knowledge and technical understanding of aseptic manufacture of biologics preferred
* Estimated salary: $85,000-$105,000 per year

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