Quality Control Data Reviewer

Hi,This is

• Perform detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC, Capillary Electrophoresis, Bioburden, endotoxin, TOC, and membrane filtration testing, generated by QC Department for compliance with cGMP, internal SOP's, and Specifications, to support production, stability studies, and lab operation.
• Review Release and Stability data, trend charts of reference standards, lab equipment calibration records, logbooks, and other review function as needed.
• Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy.
• Compile data results in accordance to SOP's and QC best practices.
• Maintain and update relevant SOP's for data review and reporting as needed and work with analysts to complete any corrections to data notebooks.
• Ensure that suitable written records and work undertaken re kept in accordance with cGMP and company procedures.
• Receive and organize Batch Records and completed Test Records and pair completed Test Records with associated Batch Records.
• Communicate and respond inquiries from internal departments regarding status of results.

• Associates degree required; Bachelor's degree preferred with 2 or more years of experience reviewing Quality Control data for cGMP compliance.
• Prior experience in reviewing microbiological assays and environmental monitoring data in a cGMP Quality Control lab required
• Prior experience in performing microbiological assays and environmental monitoring in a cGMP Quality Control lab is a plus.
• Strong attention to detail and strong organizational skills