Quality Control Review Resource I (GPV)

Job Title: Quality Control Review Resource I (GPV)
Location: Westborough, MA
Zip Code: 01581
Duration: 3 Months
Pay Rate: $45 - $50/hr.
Keyword's: #Westboroughjobs; #QualityControljobs;
Start Date: Immediate

We provide a competitive pay and benefits package. This position is offering a pay range of $45 - $50/hr. however, Belcan considers several factors when extending an offer, including but not limited to education, experience, geographic location, and discipline. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law.

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.