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Quality Assurance Associate Level III

ESR Healthcare
Allendale, NJ
November 15, 2020

Posted By Premium Recruiter


Quality Assurance Associate Level III

Responsible to perform Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs.

Essential Functions and Responsibilities

Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.

Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)

Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.

Release raw material in ERP system as well as on paper.

Perform Accessioning of incoming Apheresis.

Review Batch record and disposition material of finished product to client.

Provides information for Out of Specification and deviations to investigator.

Performs line clearance prior to manufacturing operations begins.

Supports tech transfer activities.

Other duties as assigned.


BS or higher education degree in a scientifically related field

Experience in a biologics or biotechnology company (3-4 years)

Working knowledge and technical understanding of the aseptic manufacture of biologics preferred

Working knowledge of GMP and TCTP regulations

Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)

$3000Job type:Direct hireJob function:Quality AssuranceIndustry:BiotechnologyExperience level:AssociateEducation level:Bachelor’s degreeJob classification:TechnicalLocation:Allendale, NJZip code:07401Skills:Batch records review, Documentation management, CAPA, Non-conformance, DeviationsExperience required:5 YearsRelocation assistance:NoVisa requirement:Only US citizens and Greencard holders,EAD cards