Analyst 2, Compliance
Location Novato, California Workstyle Hybrid 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.
- Investigate and complete quality records including deviations, child investigations, CAPAs, effectiveness checks, and impact assessments.
- Execute and manage change control activities for GxP facility operations.
- Review and analyze reports for critical temperature environments.
- Maintain and update compliance documentation, including SOPs, work instructions, effectiveness checks, and training materials.
- Prepare compliance reports and dashboards to track key performance indicators (KPIs).
- Conduct regular internal audits of maintenance inventory procedures and documentation to identify and mitigate compliance risks.
- Analyze data to support decision-making and provide insights on compliance and inventory management performance.
- Identify opportunities to enhance compliance and inventory management processes.
- Perform analysis on maintenance lubricants for environmental compliance.
- Assist and participate in data gathering and presentation for regulatory inspections.
- Must have 3-6 years of experience in a GMP regulated environment.
- Proficiency working in ERP systems such as SAP and Oracle
- Proficiencyworking in Veeva Quality Management System
- In-depth understanding of cGMP, FDA, and other regulatory requirements related to pharmaceutical manufacturing and inventory management.
- Proficiency in following procedures in controlled documents
- Proficiency in cause mapping such as 5 Why’s and Fishbone Diagram
- Proficiency in analyzing data and translating findings into actionable insights.
- Experience with data visualization toolssuch as Tableau and Power BI
- Experience with lean practices and the DMAIC model
- Experience with advanced cause tools such as FMEA and fault-tree analysis
- Bachelor’s Degree required such as Biology, Engineering, or Chemistry
- A combination of technical, military, and/or equivalent experience can be used in lieu of degree.
- Work experience in heavily regulated industry is preferred
In the U.S., the salary range for this position is $ 80,700 to $ 121,100 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.