Overview
Quality Control Analyst IV Jobs in Cambridge, Massachusetts, USA at Meet
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 Lab Ware LIMS, Excel, Word, and PowerPoint preferred.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance and Science
Industries
Pharmaceutical Manufacturing
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Title: Quality Control Analyst IV
Company: Meet
Location: Cambridge, Massachusetts, USA
Category: Quality Assurance – QA/QC, Healthcare
