Sunrise Systems, Inc. ยท 1 month ago
QC Microbiology Data Reviewer and Writer
Indianapolis, IN
Full-time
Onsite
Mid Level
4+ years expSunrise Systems, Inc. is a company focused on quality control in microbiology, and they are seeking a QC Microbiology Data Reviewer and Writer. The role involves reviewing microbiology data for compliance, accuracy, and completeness, as well as writing reports and supporting audits.
Information Technology & Services
Responsibilities
Perform an 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
Qualification
Required
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
Bachelor's degree in microbiology, Biology, or Biotechnology or equivalent
Preferred
SAP experience preferred
Preferred training in Quality systems, cGMP, and Data Integrity
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1000 employees
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase