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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