Quality Assurance Compliance Specialist

6 days ago


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

Lynkx Staffing LLC, a leading staffing agency specializing in the Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey, is seeking an experienced Quality Assurance Compliance Specialist. As a key member of our team, you will report directly to the Associate Manager of Quality Compliance.

Your primary responsibilities will include performing Quality Assurance Compliance activities in support of Quality Systems and/or client procedures. This encompasses document management, investigations, CAPA, SOPs, qualification and validation reports, QC data, and supporting quality management with various department, organizational, and operational excellence initiatives.

You will exercise independent judgment within generally defined practices and policies when selecting methods and techniques for obtaining solutions. Additionally, you will support internal and external audits, which may involve interaction with Health Authorities and clients.

The ideal candidate will possess a strong background in Quality Assurance, preferably in the life sciences industry, with experience in authoring, reviewing, and approving cGMP/cGTP-related documents. A thorough understanding of quality system applications, including electronic applications for training, deviations, CAPA management, etc., is also essential. Familiarity with FDA, ISO, and other regulatory agency guidelines is required.

This role requires a high level of adaptability, collaboration, accountability, and a 'can-do' pioneering spirit. You must be able to work effectively in a team-oriented environment and be available to work occasional weekends, nights, and/or holidays as required/necessary. The estimated salary for this position is $85,000-$105,000 per year, depending on experience.

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