31 Jan
Quality Control Data Reviewer
Maryland, Hanover , 21113 Hanover USA

Vacancy expired!

Hi,This is

Hershita 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 Reviewer

Location: Harmans, MD 21077

Duration: 6+ Months. (Possibility of Extension)

Job Description:

Shift:

1st Shift - M-F; 8am -5 pm

2nd shift; M-F; 4pm - 12am

Key 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.

Experience & Education:
  • 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
Thanks

Hershita SinghalTalent Acquisition Specialist Experis CORE+Phone - Ext - 7147100 Manpower Place

| Milwaukee, WI 53212

Vacancy expired!


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