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Company: Epeius Biotechnologies Corporation
Location: Pasadena
Posted on: May 11, 2018

Job Description:


This position is responsible for Quality Assurance activities which include providing daily quality assurance to operations, review batch records and production associated documentations within the manufacturing facility, provide support on Deviation, CAPA, OOS, and Change Control processes, and participate and support internal audits.

Assure compliance with GMP, GDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory guidelines and company quality practice.


Responsibilities include but are not limited to:

Work with Manufacturing as the quality assurance representative
Coordinate and facilitate Quality Assurance related production and production related activities
Ensure timely review and closure of Deviations, CAPA, Change Controls, and OOS investigations
Review batch record and production related documentation, and ensure resolution of issues to release product
Ensure approval and timely shipment of Final Product
Ensure that products are manufactured in compliance with regulatory and GMP guidelines
Review and disposition raw materials, components for GMP use
Perform --periodical internal audit and identify all areas of weakness, provide recommendations to improve those areas, monitor the effectiveness of the improvements
Obtain resolution on areas identified as non-conformance. Assess and evaluate results in terms of acceptability to standards, procedures and regulatory requirements
Quality review of analytical and stability data
Fully comply with company health and safety procedures and practices


BS degree in Biology, chemistry or related discipline with 5+, MS Degree with 3+ years--- experience working in a Biotech or Pharmaceutical FDA regulated industry
Have an in-depth knowledge of FDA regulations, applications of current Good Manufacturing Practices (cGMP)
Be able to review and approve investigations
Have a strong interpersonal skill, great team player
Have strong organizational skills and ability to plan, follow-up, and implement tasks
Be able to work independently and with intermittent supervision
Be able to operate in a dynamic, fast paced cross-functional environment
Eligible to work in the US

Keywords: Epeius Biotechnologies Corporation, Pasadena, SENIOR QUALITY ASSURANCE SPECIALIST, Other, Pasadena, California

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