Sr. Associate, Quality - Grave Shift

Location:  Novato, California Category: Quality

Description

Who We Are

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.

Senior Associate, Quality – On-Site Grave Shift
 
Responsibilities: 
-Provide on-the-floor QA oversight and support to manufacturing operations 
-Review executed batch records and associated document to ensure compliance with approved procedures and cGMP expectations 
-Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations 
-Represent QA in support of deviations including active participation in Root Cause Analysis (RCA) 
-Provide cGMP and compliance guidance to Manufacturing and Manufacturing Sciences and Technology (MSAT) personnel 
-Provide QA support including write, review, and approve documents in Quality Management Systems in accordance with BioMarin policies 
-Perform area walkthroughs 
-Perform other duties and projects as assigned by management 
 
Experience and Other Qualifications: 
-BS/BA in a scientific discipline or related field and 6-8 years experience in a biologics manufacturing environment 
-Prior batch record review experience is required 
-Prior experience in investigation, change control, other Quality Management Systems (QMS) 
-Working knowledge of cGMPs 
-Excellent written and verbal communication and interpersonal skills 
-Must display strong analytical and problem-solving skills 
-Manufacturing and MSAT experience preferred 
 
Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands.  
 
Shift Details: 
Alternate Wed, Thurs-Sat 1800-0700
**We do provide Shift Differential pay for any off-hour shifts including Swing and Grave**
No international travelling required. 

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.