QC Microbiology Data Reviewer and Writer

QC Microbiology Data Reviewer And Writer

Location: Indianapolis, IN

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, compliant 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

System One, and its subsidiaries including Joul, 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.