SCIENTIST I MICROBIOLOGY (NIGHTS)

Fresenius Kabi USA•Wilson, NC

1d•$29 - $41

About The Position

A Scientist I in Quality Control Microbiology provides intermediate-level expertise in microbiological test methods and instrumentation and participates in mentoring and training less experienced analysts. The QC Microbiology department has four functional groups, and principal activities vary by group. This role may support Environmental Monitoring, Finished Products Testing, Validations, or the Bacterial Filter Retention (BFR) Laboratory. Across groups, the role includes peer review of data; communication of operational issues, discrepancies, and out-of-limit conditions; maintaining knowledge of cGMPs, GLPs, and compendial methods; training analysts; assisting with investigations and documentation; supporting projects and root-cause investigations; updating procedures; ensuring safety practices; and maintaining equipment and calibrations not handled by metrology or maintenance. Environmental Monitoring activities include coordinating and conducting routine and non-routine monitoring of production and laboratory environments, water systems, compressed gas, and personnel; recognizing and investigating out-of-limit results; maintaining required ISO Class 5 gowning certification; processing LIMS records and release documentation; coordinating responses to environmental issues; maintaining laboratory areas and supplies; and supporting microbial identification and aseptic-technique training. Finished Products Testing activities include coordinating and conducting routine testing of in-process, finished-product, and raw-material samples; conducting environmental monitoring during bioburden and sterility testing; maintaining testing equipment; processing release documentation; and providing data for product reviews, investigations, and validation studies. Validation activities include validating microbiological test methods for new products and conducting assigned studies for products, materials, and manufacturing processes. The role executes protocols, reviews results, revises SOPs, supports equipment requalification and process validation, and performs microbiological testing for validation studies. BFR Laboratory activities include authoring and executing study protocols for sterilizing-grade filters, conducting viability, spike-flush, and filter-compatibility studies, preparing microbial suspensions and materials, monitoring laboratory conditions, reviewing peer results, supporting laboratory qualification and investigations, updating BFR procedures, and maintaining equipment. Employees are responsible for complying with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems. Employment is at-will and does not guarantee permanent employment.

Requirements

Intermediate-level expertise in microbiological test methods and instrumentation.
Knowledge of cGMPs, GLPs, and current compendial methods.
Ability to communicate work-related issues clearly and effectively.
Ability to review data for accuracy, completeness, and conformance to specifications.
For Environmental Monitoring duties, successful completion of requirements for ISO Class 5 gowning certification.
Employment is at-will; the posting does not state a specific education or years-of-experience requirement.

Responsibilities

Understand department priorities and plan work ahead.
Peer-review data for accuracy, completeness, and conformance to specifications.
Keep supervisors informed of relevant events affecting department operations, including discrepancies and out-of-limit conditions.
Communicate work-related issues clearly to management and peers.
Maintain knowledge of cGMPs, GLPs, and current compendial methods.
Teach or coordinate training modules and laboratory techniques for new analysts.
Assist in authoring investigations and other Quality Control Microbiology documents.
Support senior personnel with investigations, special testing, and project work; investigate deviations as directed and determine potential impacts and root causes.
Update microbiology test procedures, methods of analysis, and SOPs as needed.
Follow safety policies and recommend safety improvements.
Maintain equipment and perform calibrations not handled by metrology or maintenance departments.
Schedule, coordinate, and conduct routine and non-routine environmental monitoring and testing, as applicable to the assigned group.
Assess environmental conditions by sampling production and laboratory environments, water systems, compressed gas, and personnel; identify out-of-limit results and initiate investigations.
Meet requirements for ISO Class 5 gowning certification when performing Environmental Monitoring duties.
Process paperwork, LIMS entries, approvals, and data needed for QA or critical-systems release.
Coordinate responses to environmental issues and support environmental out-of-limit investigations.
Maintain laboratory housekeeping, environmental chambers, and assigned inventories of media and reagents.
Perform microbial identification activities, including sub-culture, Gram staining, culture maintenance, and processing samples for outside laboratory identification.
Assist with training manufacturing personnel in aseptic and gowning techniques as assigned.
Coordinate timely completion of routine testing and escalate unexpected results or trends.
Conduct routine testing of in-process, finished-product, and raw-material samples, as applicable to the assigned group.
Conduct environmental monitoring during bioburden and sterility testing using SKAN isolators, as applicable.
Maintain testing equipment and coordinate requalification, preventive maintenance, and calibration as needed.
Provide data for annual product reviews, investigations, and validation studies.
Validate microbiological test methods for new products and execute assigned studies for products, materials, and manufacturing processes.
Perform routine testing of in-process and finished-product samples for exhibit or process-validation batches.
Review and approve testing results and revise SOPs as required.
Execute study protocols to validate production and laboratory methods; support plant and laboratory equipment requalification and Tech Transfer process-validation protocols.
Author and execute BFR study protocols and conduct viability, spike-flush, and filter-compatibility studies, as applicable.
Prepare microbial suspensions, media, and reagents and monitor laboratory environmental conditions.
Assist with laboratory qualification and requalification studies and investigations of nonconforming test results, including root-cause and CAPA activities.
Comply with company requirements relating to Health, Safety, Environment, Energy, and Quality Management Systems.
Perform other duties as assigned.