Hi,This isHershita working as Recruitment Specialist with Experis part of Manpower Group. Please have a look at the job description and if you are interested, please reply back with an updated copy of your Resume. Please send your updated resume to () and I will be happy to have this moving swiftly. Job Role: QC Analytical Data ReviewerLocation: Harmans, MD 21077Duration: 6+ Months. (Possibility of Extension)Job Description: Shift: 1st Shift - M-F; 8am -5 pm2nd shift; M-F; 4pm - 12amKey Responsibilities include but are not limited to:
- 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