Quality Control Review Resource I (GPV)

Job Description

Job Title: Quality Control Review Resource I (GPV)
Location: Westborough, MA
Zip Code: 01581
Duration: 3 Months
Pay Rate: $50/hr.
Keyword’s: #Westboroughjobs; #QualityControljobs;
Start Date: Immediate
DESCRIPTION:
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.
Requirements:
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 MS 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.
Belcan is an equal opportunity employer. Your Application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.