QA Labs Scientist II

Summary: The QA Microbiology Analyst role involves providing technical support to manufacturing operations by ensuring compliance with microbiological testing and laboratory activities according to regulatory standards. The position requires executing test methods, supporting investigations, and maintaining environmental monitoring programs. Additionally, the analyst contributes to continuous improvement initiatives within the laboratory environment. This role is crucial for maintaining quality assurance and compliance in microbiological practices.

Key Responsibilities:

• 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
• 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
• 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
• 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
• 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
• Support environmental, health, and safety initiatives and departmental objectives
• Participate in special projects and perform additional duties as assigned

Key Skills:

• Experience in microbiological testing and laboratory practices
• Knowledge of GMP, GLP, FDA, and ISO standards
• Strong analytical and problem-solving skills
• Ability to conduct investigations and root cause analysis
• Proficiency in writing SOPs and technical documentation
• Experience with environmental monitoring programs
• Ability to train and mentor junior staff
• Strong collaboration and communication skills

Salary (Rate): £60000 yearly

City: Jacksonville

Country: United States

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

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