QA Labs Scientist II

Position Overview:
The QA Microbiology Analyst provides technical support to manufacturing operations, ensuring
microbiological testing, monitoring programs, and laboratory activities comply with company
standards and regulatory requirements (FDA, ISO, GMP). This role is responsible for executing
test methods, supporting investigations, maintaining environmental monitoring programs, and
contributing to continuous improvement initiatives within the laboratory.

Key Responsibilities:

Microbiological Testing & Monitoring:
* Perform sampling and analysis of water systems, in-process materials, pre-sterile
products, and environmental monitoring data
* Determine compliance of microbiological data with established specifications
* Conduct organism identification and perform media preparation and quality control
testing

Quality Assurance & Investigations:
* Initiate and support laboratory and non-conformance investigations, including root cause
analysis and documentation
* Review, trend, and report microbiological and sterilization data
* Ensure compliance with GMP, GLP, FDA, and ISO standards

Sterilization & Equipment Qualification:
* Execute sterilizer qualifications and support equipment validation activities
* Participate in test method validation and other qualification-related projects
* Support troubleshooting, calibration, and maintenance of laboratory equipment

Documentation & Continuous Improvement:
* Write and revise SOPs, protocols, technical reports, and investigation summaries
* Identify process improvement opportunities and recommend corrective actions
* Maintain accurate records in LIMS and ensure proper documentation practices

Collaboration & Training:
* Provide technical guidance and review work of junior staff
* Train laboratory personnel on microbiology procedures and best practices
* Collaborate cross-functionally with manufacturing, QA, and other teams
General Responsibilities:
* Support environmental, health, and safety initiatives and departmental objectives
* Participate in special projects and perform additional duties as assigned

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com