QC Micro Lab Analyst - cGMP, Data Trends & CAPA

Resilience; Port Union (OH); On-site; USD 50,000 - 72,000; Full time

Benefits offered by this job

Annual bonus

401(k) with match

Health insurance

Paid vacation

Tuition reimbursement

Job summary

Resilience is a technology-focused biomanufacturing company in Port Union, Ohio, seeking an Analyst, QC Micro - Lab to perform microbiological testing and quality control in support of the site’s control program.

Responsibilities include routine sampling, instrument maintenance, data analysis, SOP development, and audits. Requires cGMP experience and a biology/microbiology degree; on-site position with on-call availability.

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 elevate 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, utility testing, in-process testing, autoclaving, and parts washing in accordance with cGMP.
• Perform visual inspections and verify materials for correct components, quantities, and characteristics.
• Monitor equipment and systems for performance and problem indicators; troubleshoot and implement temporary and permanent fixes.
• Maintain accurate records and archived documentation (laboratory notebooks, logbooks, quality records, sample receipts) per good documentation practices, including periodic logbook reviews.
• Write, review, and revise SOPs and work instructions for cGMP manufacturing, equipment, systems, and facilities.
• Analyze data trends to identify root causes, collect and report quality metrics, and recommend corrective actions.
• Audit SOPs and work instructions to ensure compliance with regulatory requirements; elevate issues outside of SOPs to supervisor or manager.
• Interact with regulatory agency personnel during audits and inspections.
• Contribute to compliance, CAPA, and process improvement activities.
• Train others on systems, equipment, procedures, and SOPs.
• Serve as an SME cross-functionally; answer compliance and process questions and coordinate with support groups.

Skills

Microbiology

cGMP

Laboratory testing

Documentation

Education

B.S. in Biology

Microbiology degree

Tools

Laboratory instrumentation

MS Word

Microsoft Office

Job description

Resilience is a technology-focused biomanufacturing company in Port Union, Ohio, seeking an Analyst, QC Micro - Lab to perform microbiological testing and quality control in support of the site’s control program.

Responsibilities include routine sampling, instrument maintenance, data analysis, SOP development, and audits. Requires cGMP experience and a biology/microbiology degree; on-site position with on-call availability.