Associate 1/2, QA Operations

Location:  Novato, California Category: Quality

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.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY
The Novato Site QA Operations Associate I/II will report to the Gall QA Operations Manager.    Associate will support Galli production operations, responsibilities include but are not limited to:

  • Issuing controlled batch record to production staff
  • Reviewing completed production batch records, including Oracle Buffer/Media (OBM) and paper batch records
  • Preparing FBDS lots for final release
  • Provide QA support as needed on the manufacturing floor (document review, changeover, line clearance, etc.)
  • Ensure Galli production conforms to cGMPs
  • Other QA Operations duties as assigned.
EDUCATION/EXPERIENCE
  • Bachelor's degree in a science related field
  • Previous experience in cGMP field with minimum of 4 years of experience.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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