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QA Labs Scientist II

Real
  • US
    Jacksonville, Florida, United States
  • US
    Jacksonville, Florida, United States

Über

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
Desired Skills and Experience Education & Experience
Bachelor's degree in Microbiology or related scientific field
Minimum of 3 years of experience in a QA Microbiology laboratory environment
Technical Skills & Knowledge
Experience with environmental monitoring and water systems
Knowledge of aseptic techniques and microbiological testing methods
Experience with steam sterilization and sterilizer qualification
Familiarity with GMP, GLP, FDA, and ISO regulations
Experience with LIMS and laboratory documentation systems
Core Competencies
Strong analytical and problem-solving skills
Ability to write investigations, protocols, and technical reports
Strong organizational and time management skills with ability to meet deadlines
Excellent communication and interpersonal skills
Ability to work independently with moderate supervision and sound judgment
Equal Employment Opportunity 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.
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  • Jacksonville, Florida, United States

Sprachkenntnisse

  • English
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