Quality Control Microbiologist

The Quality Control Microbiology Technician plays an essential role in maintaining the quality, safety, and compliance of our manufacturing environment. This position supports the Environmental Monitoring Program , evaluates and trends environmental data, documents deviations, and performs approved microbiological testing within an ISO Class 8 cleanroom environment . In addition to microbiology responsibilities, the Technician will support key Quality Control activities, including incoming materials management, label control, cleaning validation/verification, and contamination-related investigations . This is an excellent opportunity for a detail-oriented laboratory professional who enjoys working in a regulated manufacturing environment and takes pride in maintaining high standards of quality and compliance. Key Responsibilities Routinely monitor temperature, pressure, and humidity within production areas using air samplers, growth/media plates, environmental sensors, and applicable software systems. Perform environmental monitoring activities using appropriate aseptic techniques while properly donning and maintaining required personal protective equipment (PPE). Collect samples and document results associated with third-party laboratory testing , including environmental monitoring plates, endotoxin testing, and quarterly inspection testing. Perform sampling activities supporting cleaning validations and verifications . Develop clear and informative charts, graphs, and trend reports for presentation to cleanroom personnel and Asteria Health Operations and Quality teams on a monthly basis. Identify and report out-of-specification (OOS) test results to management in accordance with established procedures. Support the review and improvement of microbiological procedures, including recommendations for SOP revisions and change controls based on observations and test results. Assist with non-conformance investigations, deviations, and Corrective and Preventive Actions (CAPA) related to contamination and environmental monitoring. Support training and qualification activities for personnel performing environmental monitoring in accordance with approved SOPs and Work Instructions . Serve as a role model for proper gowning and cleanroom practices for personnel working in ISO Class 8 areas. Incoming Materials & Quality Control Maintain accurate inventory records and document the receipt of incoming materials and supplies used for testing. Prepare and organize required documentation, specifications, and supporting records for incoming material approval . Properly label, segregate, and store approved materials in accordance with applicable regulations, company policies, and procedures. Support the overall integrity and accuracy of Quality Control documentation and records. Product Label Control Print product labels in accordance with documented specifications for each product and production lot. Perform routine cleaning, inspection, and maintenance of the product label printer. Accurately document labeling activities within production batch records. Maintain proper segregation and control of labels for distinct production lots. Coordinate with Production and Operations to ensure labels are appropriately issued and controlled for their respective lots. Qualifications & Experience Continued education in Biology, Microbiology, or a related scientific field , plus approximately two years of experience working in a laboratory or cleanroom environment. Equivalent combinations of education and experience may be considered, including approximately two years of experience in a microbiology laboratory or environmental monitoring program within a cleanroom. Working knowledge and practical experience with current Good Manufacturing Practices (cGMP) and related regulatory requirements. Demonstrated understanding of microbiological concepts, laboratory practices, and environmental monitoring procedures. Experience working in a production, manufacturing, pharmaceutical, biotechnology, or other regulated environment is preferred. Strong written and verbal communication skills . Exceptional attention to detail , organization, and documentation skills. Strong work ethic and commitment to quality. Ability to work effectively independently with minimal supervision as well as collaboratively within a team. Proficiency with computers, including data entry, Microsoft Office, email, internet-based systems, ZenQMS, and inventory management software . Work Environment & Physical Requirements Ability to properly gown and work within an ISO Class 8 cleanroom environment . Ability to follow established safety procedures when working with Active Pharmaceutical Ingredients (APIs) and microbiological organisms. Ability to work in a variety of positions and locations, including sitting, standing, squatting, kneeling, reaching, and walking , potentially for extended periods. Ability to safely and effectively operate equipment and technology, including computers, scanners, phones/headsets, and other assigned devices . Ability to work effectively in a team environment and remain flexible and adaptable as priorities, assignments, and business needs change. What Success Looks Like Success in this role requires a strong commitment to quality, accuracy, compliance, and teamwork . The ideal candidate is comfortable working in a highly regulated environment, follows procedures carefully, recognizes potential quality issues, communicates concerns promptly, and takes initiative to support continuous improvement. Disclaimer: This job description is intended to describe the general nature and level of work performed in this position. It is not intended to be an exhaustive or comprehensive list of all duties, responsibilities, or qualifications required of the employee. Duties and responsibilities may be modified as business needs evolve. #J-18808-Ljbffr Express Employment Professionals - Birmingham, AL South