Job Description

*W2 Only

Overview:

The Analyst IV is responsible for ensuring quality and compliance standards are met to support the commercialization of pharmaceutical/biotech programs. This role ensures completeness, consistency, and accuracy of regulatory filings, laboratory data, and reports through thorough review processes. This position offers remote flexibility with occasional on-site presence in Norton, MA, and Cambridge, MA, and potential travel to CMO/CTL sites.

Key Responsibilities:

• Verify integrity and traceability of regulatory dossier sections against reference methods and reports.
• Review analytical data for accuracy, completeness, and correct entries, including electronic data and laboratory documentation (notebooks, worksheets, logbooks).
• Ensure complex notebooks for analytical method validation, verification, and transfer testing are compliant with approved protocols.
• Audit electronic data trails to confirm adherence to applicable procedures.
• Resolve data discrepancies with clients and ensure all corrections are implemented.
• Adhere to SOPs and cGMP standards, providing management with regular updates on deviations or discrepancies.
• Suggest improvements to the review process and perform other assigned duties as needed.

Qualifications:

• B.S. in Chemistry, Biology, Biochemistry, or related scientific field.
• Minimum 5 years of experience in GMP Quality Control within the pharmaceutical/biotech industry.
• Experience with method transfer, analytical method implementation, and method lifecycle management.
• Strong technical writing, data analysis, and problem-solving skills, including CAPA implementation.
• Excellent organizational, communication, and teamwork abilities.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

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