Quality Assurance Microbiologist

Ultipro

Houston (TX)

On-site

USD 65,000 - 90,000

Full time

7 hours ago
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Job summary

Eagle Analytical Houston is seeking a Quality Control Microbiologist to perform reviews of sterile and non-sterile microbiology data, ensuring compliance with cGMP, cGLP, ISO 17025, A2LA and USP requirements. You will help maintain data integrity and support investigations and CAPAs in a regulated lab environment.

Responsibilities include reviewing data, preparing audit findings, supporting regulatory inspections, and maintaining controlled documentation.

Qualifications

  • Bachelor’s degree in Microbiology or a related life science.
  • Experience in sterile and non-sterile microbiology testing preferred.
  • Knowledge of ISO 17025, cGMP, cGLP, USP, and A2LA is a plus.
  • Strong attention to detail and data integrity.
  • Excellent written and verbal communication skills.
  • Ability to work independently and with cross-functional teams.
  • Proficiency with Microsoft Office and electronic document management systems.
  • ASQ certification or related quality credentials preferred.

Responsibilities

  • Review microbiology data and documentation for sterility, endotoxin, and microbial limits.
  • Interpret regulatory and accreditation standards and apply them to QA activities.
  • Support inspections, client audits, and accreditation assessments.
  • Write, review, and approve CAPAs, NCRs, OOS, and change controls.
  • Prepare audit findings and corrective actions.
  • Maintain quality records and controlled documentation.
  • Conduct internal quality system audits and walk-throughs.
  • Manage storage, retention, and quarantined materials.
  • Communicate findings and risks to quality leadership.
  • Assist in continuous improvement initiatives in quality systems.

Skills

Data integrity
Regulatory compliance
SOPs
QMS
Audit support
Documentation review
Quality investigations
MS Office
LIMS
ASQ credentials

Education

Bachelor's in Microbiology or related life science

Tools

LIMS
MS Excel
EDMS

Job description

Eagle Analytical Houston is seeking a Quality Control Microbiologist to perform reviews of sterile and non-sterile microbiology data, ensuring compliance with cGMP, cGLP, ISO 17025, A2LA and USP requirements. You will help maintain data integrity and support investigations and CAPAs in a regulated lab environment.

Responsibilities include reviewing data, preparing audit findings, supporting regulatory inspections, and maintaining controlled documentation.

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