Associate 1, Quality (Grave Shift)
Location Novato, California Workstyle Onsite Only ApplyWho 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.
Associate 1, Quality – On-Site Grave and Weekend Shift
Responsibilities:
-Provide on-the-floor QA oversight and support to manufacturing operations
-Review executed batch records and associated documents 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 Novato Technical Services (NTS) personnel
-Provide QA support including authoring, review, and approval of 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 3-5 years experience in a biologics manufacturing environment
-Prior batch record execution or review experience
-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 Manufacturing Sciences 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
**Wedoprovide 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.
In the U.S., the salary range for this position is $ 76,000 to $ 114,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.