ECLARO ยท 4 days ago
QC Microbiology Data Reviewer and Writer
Indianapolis, IN
Contract
Onsite
Mid Level
$57/hr - $60/hr
4+ years expECLARO is a company that delivers life-changing healthcare solutions, and they are seeking a QC Microbiology Data Reviewer and Writer for their client in the Biopharmaceutical Industry. The role involves reviewing QC microbiology data for compliance and accuracy, ensuring documentation integrity, and supporting audits.
Staffing & Recruiting
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
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
Benefits
401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
Company
ECLARO
ECLARO is an award-winning professional services firm headquartered in New York City and operating in the U.S., Canada and the Philippines.
1001-5000 employees
H1B Sponsorship
ECLARO 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
2025 (1)
2024 (1)
2023 (1)
2022 (2)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Nicholas Butcher
QA CTO Label Specialist
Dan Broderick
Chief Delivery Officer
Company data provided by crunchbase