QC Micro Lab Analyst (cGMP) – Quality & Compliance

National Resilience

United States

On-site

USD 33,000 - 48,000

Full time

9 days ago

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Benefits offered by this job

Annual cash bonus
401(k) plan with company match
Healthcare benefits
Paid vacation

Job summary

Resilience in the United States seeks an Analyst, QC Micro – Lab to perform microbiological testing and QC activities supporting the site’s microbiological control program. You will write, review, and revise SOPs, monitor trends, and ensure compliance with cGMP and FDA regulations.

The role requires experience in a regulated lab, strong documentation practices, and ability to work with cross-functional teams. On-site schedule is Monday–Friday with on-call support.

Qualifications

  • Experience performing microbiological testing or analytical laboratory work in a regulated or cGMP environment.
  • Ability to independently apply laboratory skills within own job area, drawing on microbiological knowledge and cGMP experience.
  • Ability to analyze laboratory data, identify trends or deviations, and communicate observations and recommendations to supervisor.
  • Working knowledge of cGMP documentation requirements (logbook practices, deviation identification, SOP compliance).
  • Ability to prepare clear, accurate technical documentation consistent with cGMP requirements.

Responsibilities

  • Perform routine sampling and testing in accordance with cGMP.
  • Inspect materials for correct components, quantities, and characteristics.
  • Monitor equipment performance and troubleshoot issues.
  • Maintain accurate lab records per good documentation practices.
  • Write, review, and revise SOPs and work instructions for cGMP.
  • Analyze data trends, report quality metrics, and recommend corrective actions.
  • Audit SOPs for regulatory compliance and escalate issues.
  • Interact with regulatory agencies during audits.
  • Contribute to CAPA and process improvement.
  • Train others on systems, equipment, procedures, and SOPs.
  • Serve as SME cross-functionally and coordinate with support groups.
  • Communicate policies and procedures across levels.
  • Use CMMS to manage logistics.

Skills

Microbiological testing
Lab skills
Data analysis
cGMP documentation
Technical writing

Education

Bachelor's degree in biology/microbiology

Tools

MS Word
Microsoft Office

Job description

Resilience in the United States seeks an Analyst, QC Micro – Lab to perform microbiological testing and QC activities supporting the site’s microbiological control program. You will write, review, and revise SOPs, monitor trends, and ensure compliance with cGMP and FDA regulations.

The role requires experience in a regulated lab, strong documentation practices, and ability to work with cross-functional teams. On-site schedule is Monday–Friday with on-call support.

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