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Full-time Quality Assurance Associate Level II - 1

at KLM Careers in New Jersey



Quality Assurance Associate Level II - 1

Allendale, NJ 07401

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.

Required Knowledge, Skills, and Abilities: (Submission SummaryJ

1. BS or higher education degree in a scientifically related field

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



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

4. Working knowledge of GMP and TCTP regulations



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


Reference : Quality Assurance Associate Level II - 1 jobs


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Published at 01-12-2020
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