QC Microbiology Data Reviewer

We at ELIQUENT are looking for an experienced QC Microbiology Data Reviewer to immediately join our ELIQUENT Engineering - Chicago team. The Data Reviewer will be responsible for the timely and accurate review of microbiological test data, documentation, and laboratory records to ensure compliance with regulatory requirements, internal procedures, and Good Manufacturing Practices (GMP). This role provides a critical quality oversight function by verifying data integrity, identifying discrepancies, and ensuring all laboratory results meet established standards before release.

ESSENTIAL DUTIES AND 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.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor’s degree in scientific discipline required or equivalent work experience.
• 2 or more years microbiology experience
• Previous experience in data review, quality assurance, or microbiology testing strongly preferred.
• 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.

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.