Sr. Analyst / Associate 1, QC Critical Reagents

Role Summary

The QC Critical Reagents Associate / Sr. Analyst is accountable for maintaining all aspects of the BioMarin Critical Reagents program for commercial products in the global network, including but not limited to maintaining material inventory, generating technical documentation, and supplying materials to the global testing network. Materials in the Critical Reagents program include qualified reagents, reference standards, custom reagents, analytical cell banks and other important materials that require dedicated oversight. The individual prepares trend graphs and analyses for Critical Reagents to support routine requalification activities, regulatory responses, and investigational activities.

Responsibilities

• Associate I:
  • Acts as lead for at least 1 commercial program Critical Reagent portfolios.
  • Author critical reagent technical documentation, including protocols and reports for qualification, requalification, expiry extension, qualified ranges, etc.
  • Perform review and data verification of technical documentation.
  • Maintains critical reagent trending graphs to monitor material stability, assay performance and suitability of qualified ranges, and to support technical documentation.
  • Maintains critical reagent inventory and participates in forecasting of critical reagents supply demands and identifying resupply trigger points.
  • Responsible for critical reagent acquisition, preparation, qualification testing coordination and release for use.
  • Supports critical reagent distributions for the global testing network.
  • Authors documentation, data compilation and analysis for regulatory submissions (BLA, MAA, etc.) and response letters (RTQs, etc.) for commercial products.
  • Utilizes LIMS to document acquisition and preparation of critical reagents, to monitor testing status of critical reagents, and to extract data for trend analyses.
  • Contributes expertise to the development, implementation and maintenance of critical reagents inventory management and data trending tools for hands-on use by the Quality organization.
  • Initiates, completes and provide SME input for Quality Management Systems (QMS) processes, such as Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPAs).
  • Participate in projects to meet timelines to ensure on-time delivery of results and establish priorities for final reports.
  • Participate in the generation of new ideas to create efficiencies and improve processes; engages in continuous improvement.
  • Assist with regulatory and internal inspections, as needed.
  • Attend team huddles and department meetings as required.
  • Other duties as assigned.
• Sr. Analyst:
  • Author critical reagent technical documentation, including protocols and reports for qualification, requalification, expiry extension, qualified ranges, etc.
  • Perform review and data verification of technical documentation.
  • Maintains critical reagent trending graphs to monitor material stability, assay performance and suitability of qualified ranges, and to support technical documentation.
  • Maintains critical reagent inventory and participates in forecasting of critical reagents supply demands and identifying resupply trigger points.
  • Responsible for critical reagent acquisition, preparation, qualification testing coordination and release for use.
  • Coordinates and executes critical reagent distributions for the global testing network.
  • Supports document authoring, data compilation and analysis for regulatory submissions (BLA, MAA, etc.) and response letters (RTQs, etc.) for commercial products.
  • Utilizes LIMS to document acquisition and preparation of critical reagents, to monitor testing status of critical reagents, and to extract data for trend analyses.
  • Supports development, implementation and maintenance of critical reagent inventory management and data trending tools for hands-on use by the Quality organization.
  • Initiates, completes and provide SME input for Quality Management System (QMS) processes, such as Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPAs).
  • Participate in projects to meet timelines to ensure on-time delivery of results and establish priorities for final reports.
  • Participate in the generation of new ideas to create efficiencies and improve processes; engages in continuous improvement.
  • Assist with regulatory and internal inspections, as needed.
  • Attend team huddles and department meetings as required.
  • Other duties as assigned.

Experience

Required Skills

• Sr. Analyst: Minimum 1 year relevant experience
• Associate 1: Minimum 3 years relevant experience
• Experience with quality management systems, current Good Manufacturing Practices (cGMP), and detailed knowledge of QC principles and compliance requirements.
• Excellent documentation, written and verbal communication skills.
• Computer literacy is required, including proficiency with Microsoft Word and Excel.
• Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or process requirements.

Desired Skills

• Sr. Analyst:
  • At least 2 years of relevant experience preferred
  • Working understanding of analytical testing in a cGMP environment (enzymatic activity, HPLC/UPLC, cell-based bioassay, etc.)
• Associate 1:
  • At least 4 years relevant experience preferred
  • Experience managing cGMP critical reagent/reference standard programs
  • Experience performing analytical testing in a cGMP environment (enzymatic activity, HPLC/UPLC, cell-based bioassay, etc.)
• Working understanding of sample handling and transfer in a cGMP environment
• Demonstrated working knowledge and critical thinking with respect to functional activities.
• Works with ambiguity and complexity to continuously modify options and solutions.
• Applies sound problem-solving skills to recommend options and implement effective solutions.
• Experience with Microsoft PowerPoint, Teams, Projects and/or Visio is desired.
• Familiar with relevant regulations, including 21CFR, USP, EP, and ICH requirements.

Education

• Bachelor‚Äôs degree in a related field, or Associate‚Äôs degree with additional relevant experience

Equipment

• Standard lab equipment, such as pipettes, balances, pH Meter, Biological Safety Cabinet, etc.
• Controlled Temperature Environments (CTEs), such as refrigerators and freezers
• Computer with statistical analysis and LIMS electronic softwares

Shift Details

• Primary working hours: Monday ‚Äì Friday, day shift business hours (Pacific Time)
• Requires some flexibility to attend meetings outside of standard business hours to work with colleagues in other time zones
• Flexibility for hybrid schedule, preferred 4 days on-site