• QC Microbiology Data Reviewer and Writer

    System One (Indianapolis, IN)


    Job Title: QC Microbiology Data Reviewer and Writer

     

    Hours/Schedule: Monday - Friday, Business Hours

     

    Type: Contract

    Overview

    Leading pharmaceutical company looking for an experienced QC Microbiology Data Reviewer. Ideal candidates should have 4 years of experience in GMP Microbiology laboratory data Review. As well as experience writing and supporting investigations, deviations, or CAPA processes.

    Responsibilities

    • Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance

    • Verify raw data, calculations, instrument outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoring

    • Confirm adherence to SOP’s, test methods, and approved protocols

    • Ensure documentation meets ALCOA+ data integrity principles

    • Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentation

    • Review EM results and ensure proper escalation of out of trend or excursions findings

    • Write deviations, CAPAs and revise SOP’s

    • Write monthly / quarterly reports for environmental monitoring

    • Support internal and external audits by providing clear, complaint documentation

    Requirements

    Qualifications

    • Minimum 4 years’ experience in GMP microbiology laboratory data review

    • Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring

    • Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.

    • Experience with Sherpa or other LIMS

    • Intermediate level MS SharePoint experience

    • SAP experience preferred

    Education:

    • Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent

    • Preferred training in Quality systems, cGMP, and Data Integrity

     

    Benefits

     

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

     

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.