QA Reviewer: Associate Scientist I (Microbiology)

ABOUT PROMPT PRAXIS LABORATORIES

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients. Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and a commitment to ongoing professional development. Join PPL and build a career defined by excellence and impact.

THE ROLE

The Quality Assurance (QA) Microbiology Associate Scientist I supports PPL's quality assurance program by performing independent review of microbiology testing data generated in a cGMP-regulated laboratory environment. This role focuses on verification-based review of microbiological test records where results are clearly defined (e.g., Pass/Fail) and do not require interpretation of analytical output. The position ensures that all testing activities, documentation, and reported outcomes are accurate, complete, and compliant with regulatory and internal quality standards. This role is ideal for early-career professionals seeking to build QA experience in a microbiology laboratory setting.

PRIMARY RESPONSIBILITIES

Perform independent review of microbiology testing records for compliance with cGMP requirements and internal procedures Verify completeness and accuracy of test documentation, including, environmental monitoring results, bioburden / endotoxin / sterility test records, and Growth promotion and media qualification Confirm that results are recorded and aligned with applicable acceptance criteria (Pass/Fail) Ensure all required documentation (worksheets, logs, forms) is complete and GMP compliant Verify that testing is performed in accordance with SOPs, methods, and specifications Ensure deviations, OOS, or atypical results are properly documented and escalated, as necessary Data Integrity & Regulatory Compliance Ensure laboratory documentation complies with cGMP and ALCOA+ data integrity principles. Verify audit trail awareness (where applicable) Escalate discrepancies or documentation gaps identified during documentation review Support audit and inspection readiness as Subject Matter Expert Work closely with QC Microbiology and QA teams to resolve documentation issues Communicate findings clearly and constructively Support continuous improvement of microbiology QA review processes Contribute to maintaining a strong culture of quality and compliance Collaboration & Continuous Improvement Work closely with QC Microbiology and QA teams to resolve documentation issues Communicate findings clearly and constructively Support continuous improvement of microbiology QA review processes Contribute to maintaining a strong culture of quality and compliance

DESIRED QUALIFICATIONS

Bachelor's degree in Microbiology, Biology, or related life science 2 years of experience in a microbiology or cGMP lab environment Basic understanding of microbiological testing methods Familiarity with cGMP and documentation practices (preferred) Strong attention to detail and organizational skills Effective communication skills Ability to follow structured processes with consistency

Job Type:

Full-time Pay:

$55,000.00 - $65,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance

Work Location:

In person