Sr. Analyst / Associate 1, QC Critical Reagents

BioSpace; Novato (CA); Hybrid; USD 70,000 - 90,000; Full time

Job summary

A biotechnology company in Novato is seeking a Sr. Analyst/Associate 1 to manage critical reagent documentation and inventory. Applicants should have experience in quality management systems and a relevant degree. The role includes liaising with global testing networks and supporting regulatory submissions. A hybrid schedule is preferred with competitive benefits.

Qualifications

• Minimum 1 year relevant experience for Sr. Analyst and 3 years for Associate 1.
• Experience with quality management systems and cGMP.
• Excellent documentation, written and verbal communication skills.

Responsibilities

• Lead commercial program critical reagent portfolio.
• Maintain critical reagent trending graphs and inventory.
• Support regulatory submissions and inspections.

Skills

Documenting and communication skills

Quality service attitude

Flexibility and adaptability

Education

Bachelor's degree in a related field

Tools

Microsoft Word

Microsoft Excel

LIMS software

Job description

Overview

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Sr. Analyst / Associate 1, QC Critical Reagents

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Using our expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. BioMarin’s Technical Operations group creates drugs for clinical trials and scales production for the commercial market, ensuring quality and regulatory compliance across manufacturing sites and the global testing network.

Responsibilities

• Associate I: Acts as lead for at least 1 commercial program Critical Reagent portfolio.
• Associate I: Author critical reagent technical documentation, including protocols and reports for qualification, requalification, expiry extension, qualified ranges, etc.
• Associate I: Perform review and data verification of technical documentation.
• Associate I: Maintain critical reagent trending graphs to monitor material stability, assay performance and suitability of qualified ranges, and to support technical documentation.
• Associate I: Maintain critical reagent inventory and participate in forecasting of critical reagents supply demands and identifying resupply trigger points.
• Associate I: Responsible for critical reagent acquisition, preparation, qualification testing coordination and release for use.
• Associate I: Support critical reagent distributions for the global testing network.
• Associate I: Author documentation, data compilation and analysis for regulatory submissions (BLA, MAA, etc.) and response letters (RTQs, etc.) for commercial products.
• Associate I: Utilize LIMS to document acquisition and preparation of critical reagents, monitor testing status, and extract data for trend analyses.
• Associate I: Contribute to development, implementation and maintenance of critical reagents inventory management and data trending tools for use by the Quality organization.
• Associate I: Initiate and provide SME input for QMS processes (Change Controls, Deviations, CAPAs, etc.).
• Associate I: Participate in projects to meet timelines and establish priorities for final reports.
• Associate I: Generate ideas to create efficiencies and improve processes; support continuous improvement.
• Associate I: Assist with regulatory and internal inspections as needed.
• Associate I: Attend team huddles and department meetings as required.
• Associate I: Other duties as assigned.
• Sr. Analyst: Author critical reagent technical documentation, including protocols and reports for qualification, requalification, expiry extension, qualified ranges, etc.
• Sr. Analyst: Perform review and data verification of technical documentation.
• Sr. Analyst: Maintain critical reagent trending graphs to monitor material stability, assay performance and suitability of qualified ranges, and to support technical documentation.
• Sr. Analyst: Maintain critical reagent inventory and participate in forecasting of critical reagents supply demands and identifying resupply trigger points.
• Sr. Analyst: Responsible for critical reagent acquisition, preparation, qualification testing coordination and release for use.
• Sr. Analyst: Coordinate and execute critical reagent distributions for the global testing network.
• Sr. Analyst: Support document authoring, data compilation and analysis for regulatory submissions (BLA, MAA, etc.) and response letters (RTQs, etc.) for commercial products.
• Sr. Analyst: Utilize LIMS to document acquisition and preparation of critical reagents, monitor testing status, and extract data for trend analyses.
• Sr. Analyst: Support development, implementation and maintenance of critical reagent inventory management and data trending tools for hands-on use by the Quality organization.
• Sr. Analyst: Initiate and provide SME input for QMS processes (Change Controls, Deviations, CAPAs, etc.).
• Sr. Analyst: Participate in projects to meet timelines and establish priorities for final reports.
• Sr. Analyst: Participate in the generation of new ideas to create efficiencies and improve processes; engage in continuous improvement.
• Sr. Analyst: Assist with regulatory and internal inspections as needed.
• Sr. Analyst: Attend team huddles, department meetings and standard work 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, cGMP, and detailed knowledge of QC principles and compliance requirements.
• Excellent documentation, written and verbal communication skills.
• Computer literacy with Microsoft Word and Excel.
• Quality service attitude, 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 critical thinking and problem-solving skills
• Ability to work with ambiguity and complexity to develop solutions
• Experience with PowerPoint, Teams, Projects and/or Visio is preferred
• Familiar with regulations (21 CFR, USP, EP, ICH)

Education

• Bachelor’s degree in a related field, or Associate’s degree with additional relevant experience

Equipment

• Standard lab equipment (pipettes, balances, pH meter, BSC, etc.)
• Controlled Temperature Environments (refrigerators, freezers)
• Computer with statistical analysis and LIMS software

Shift Details

• Primary hours: Monday – Friday, day shift (Pacific Time)
• Some meetings outside standard hours as needed for global collaboration
• Hybrid schedule preferred; 4 days on-site

Note: This description is not intended to be all-inclusive. It describes the general nature of the job and may include other duties as assigned.

Equal Opportunity Employer/Veterans/Disabled

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Biotech / Pharmaceuticals