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Quality Assurance Associate

Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 21043-AB1
Compensation : 70000.00 - 80000.00 USD/YEAR
Start Date : 05/17/2022
Hours : Full Time
Required Years of Experience : 1-2
Required Education : BS Life Science
Travel : No
Relocation : No
Job Industry : Biotechnology

Job Description :

  • Permanent position for a Quality Assurance Associate II to support of Quality Systems and client procedures.

  • Conduct activities including document management, review of QC data, material releases and final product releases.

  • Ensure all procedures and processes meet pre-clinical, clinical and commercial manufacturing internal quality standards and external regulations, including cGMP and cGTP compliance.

  • Read, understand and follow cGMP and cGTP Quality System documentation including SOPs and Wis.

  • Accessioning of incoming Apheresis.

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

  • Release raw material in ERP system,

  • Provide information for Out of Specification and deviations to investigator.

  • Perform line clearance prior to manufacturing operations begins.

Required Qualifications :

  • BS Life Science

  • Minimum 1 year of biotechnology experience.

  • Knowledge and technical understanding of the aseptic manufacture of biologics

  • Experience in reviewing validation and qualification reports, SOPs and other cGMP / cGTP related documents.

  • Ability to work in a team-oriented environment and with clients.

  • Compressed workweek: Sunday-Wednesday, 1st shift, 10 hour days.

Contact: Allan Berman

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