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Quality Assurance Lot Release (QALR) Specialist (Temporary) - United States  

Biomarin (company)

Posted on : 20 April 2017

Project Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

This position is responsible for performing BioMarin Quality Assurance (QA) review of BioMarin commercial manufacturing batch records and associated documentation.   This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases.  QA review of commercial manufacturing batch records includes verifying conformance to cGMPs and BioMarin SOPs and batch record process limits.    

This position is a junior level individual contributor position.  The individual is expected to be capable of performing routine job functions with minimal supervision.  The Specialist I/II is expected to communicate well with Manufacturing, Quality Assurance, and Quality Control. 

  • Perform BioMarin QA review of BioMarin Commercial Manufacturing executed batch records and associated documentation for compliance with cGMPs, BioMarin SOPs, and other BioMarin polices and procedures.
  • Receive, control, scan and archive BioMarin Commercial Manufacturing executed batch records.
  • Review electronic data in Oracle EBS and compare with Paper batch records for consumption.
  • Prepare lot history folders for Novato formulated bulk drug substance (FBDS) lots.
  • Other QA Lot Release duties as assigned.
  • For Specialist I, 0-2 years of directly related experience in a GMP Quality or Manufacturing environment.  

Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.