Clark & Enersen · 1 month ago
QC Microbiology Data Reviewer
Indianapolis, IN
Full-time
Hybrid
Entry, Mid Level
$85K/yr - $95K/yr
2+ years expClark & Enersen is seeking an experienced QC Microbiology Data Reviewer to join their ELIQUENT Engineering team in Chicago. The role involves reviewing microbiological test data and documentation to ensure compliance with regulatory standards and Good Manufacturing Practices, while providing critical quality oversight.
Consulting
Responsibilities
Perform detailed review of microbiology laboratory data (e.g., bioburden, endotoxin, environmental monitoring, sterility, microbial identification, growth promotion, water testing)
Verify that analysts followed approved methods, SOPs, and protocols
Ensure data integrity in accordance with ALCOA+ principles and GMP requirements
Confirm completeness, accuracy, and legibility of laboratory notebooks, worksheets, electronic records, and logbooks
Review calculations, instrument printouts, and raw data for accuracy and consistency
Check test results against acceptance criteria and notify appropriate stakeholders of any deviations or OOS/OOT results
Support investigations for deviations, OOS/OOT, and laboratory errors by providing data review insights
Ensure timely escalation of discrepancies, incomplete records, or compliance concerns
Review and approve laboratory reports, certificates of analysis, and trending summaries
Identify gaps or recurring issues in laboratory documentation practices and recommend improvements
Collaborate with lab analysts, supervisors, and QA to ensure consistent data quality
Assist with revisions to SOPs, forms, and templates to improve clarity and compliance
Qualification
Required
Bachelor's degree in scientific discipline required or equivalent work experience
2 or more years microbiology experience
Proficiency in microbiological lab techniques and test principles (e.g., aseptic techniques, incubation, plate reading, microbial identification)
Working knowledge of GMP, GLP, and data integrity standards (ALCOA+)
Familiarity with laboratory software, electronic documentation systems, and standard laboratory instrumentation
Strong attention to detail and ability to identify data inconsistencies
Excellent written and verbal communication skills
Strong organizational and time-management abilities
Ability to work independently and collaboratively in a fast-paced environment
Preferred
Previous experience in data review, quality assurance, or microbiology testing strongly preferred
Benefits
Health, dental, vision, and life insurance
A 401(k) plan with employer match
A generous paid time off policy
Additional perks
Company
Clark & Enersen
Clark & Enersen was founded in 1946 in by Architect Kenneth B. Clark and Landscape Architect Lawrence A.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase