Analyst 2, Compliance

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Job 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.

Compliance Analyst 2 SUMMARY The Compliance Analyst 2 serves as an integral member of the Maintenance Operations team. This position is responsible for ensuring all facilities operations meet regulatory compliance standards. The Compliance Analyst 2 will play a crucial role in maintaining a compliant, safe, and efficient work environment while adhering to GMP and FDA industry regulations. The ideal candidate will have experience working in a cGMP environment with experience in compliance, maintenance processes, change control, data analysis, investigations, and data presentation. This position requires a detail-oriented individual with the ability to analyze complex changes and investigations, and who can work collaboratively with cross-functional teams to maintain optimal inventory levels and support the company's operational goals. RESPONSIBILITIES

• 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.

EXPERIENCE Required Skills:

• Must have 3-6 years of experience in a GMP regulated environment.

• Proficiency working in ERP systems such as SAP and Oracle

• Proficiency working 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.

Desired Skills:

• Experience with data visualization tools such 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

EDUCATION

• 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

EQUIPMENT N/A CONTACTS There will be extensive contact with staff in Maintenance, Engineering, Planning & Scheduling, and Manufacturing. SHIFT DETAILS This position must be available during regular business hours, Monday through Friday, 8 hours a day. ONSITE, REMOTE, OR FLEXIBLE This is a flexible style position, requiring 3 on-site days per week. TRAVEL REQUIRED No travel is required for this position. 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.

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