Quality Control Review Resource I (GPV)

Position Title: Quality Control Review Resource I (GPV) Work Location: Westborough, MA, 01581 Assignment Duration: 03 Months (Possible extension) Work Arrangement: OnsitePosition Summary: Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources for aggregate reports. Performs data integrity review of CMC data and reports intended for regulatory filings. Key Responsibilities: Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources for aggregate reports. Performs data integrity review of CMC data and reports intended for regulatory filings. Ensures integrity, accuracy, and consistency of data and documents. Record QC metrics per defined categories. Qualifications & Experience: BA/BS or equivalent with typically 3+ years relevant experience in a biotechnological and/or pharmaceutical Quality Assurance setting. Experience in a pharmaceutical development environment with knowledge and review experience on development study protocols and reports for investigational stage products. Excellent oral and written communication skills. Ability to perform and verify mathematical determinations utilizing both calculator and computer programs, such as Excel. Ability to work effectively in a matrix setting to resolve issues and achieve common goals. Preferred: Previous experience with cell therapy development or cell-based assays (technical or quality review). Experience working under GxPs and/or knowledge of GMP, ICH, USP and global compendial regulations and guidance.