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Microbiological Quality Assurance Specialist

2 months ago

Marion, North Carolina, United States Integrated Resources, Inc ( IRI ) Full time

Position Overview

As a Microbiological Quality Assurance Specialist, you will play a crucial role in maintaining the integrity of our production environment. Your responsibilities will include:


• Environmental Monitoring: Collect environmental samples across the facility in accordance with established Standard Operating Procedures at designated intervals.


• Water Sampling: Conduct daily, weekly, and monthly water sample collections throughout the facility.


• Sample Processing: Analyze water samples for Microbial Total Count and Coliform.


• Physical Requirements: Safely navigate ladders and scaffolding for sampling tasks.


• Risk Assessments: Execute weekly Real Time Risk Assessments (RTRA) to pinpoint potential contamination risks in cleanroom environments.


• Documentation Review: Ensure thorough documentation and testing of Environmental Events/Deviations before approval submission.


• Collaboration: Build strong partnerships with Quality Operations, Manufacturing, and Engineering teams to address issues identified on the production floor.


• Investigation Leadership: Lead investigations into microbial out-of-limit occurrences, determining root causes and implementing effective corrective and preventive actions.


• Cross-Functional Interaction: Work closely with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure timely resolution of issues.


• Communication: Provide updates on investigation progress to all levels of staff.


• Investigation Closure: Ensure timely closure of investigations to meet business and compliance objectives.


• Multi-tasking: Manage multiple investigations simultaneously while adhering to required testing timelines.


• Validation Coordination: Collaborate with Technical Services and the Microbiology Group on validation protocols.


• Work Environment: Maintain a clean and safe workspace, applying 6S principles.

Qualifications


• A Bachelor’s degree in Microbiology, Biology, or a related scientific field.


• 0-2 years of relevant experience; at least 1 year in the Pharmaceutical or Medical Device sector is preferred.


• Experience in conducting root cause analyses within the pharmaceutical or medical products industry is advantageous.


• Strong communication and project management capabilities.


• Familiarity with core manufacturing and support systems.


• Proficiency in Microsoft Office applications (Word, Excel).


• Excellent interpersonal skills and the ability to thrive in a team-oriented environment.


• Competence in aseptic techniques and handling of media plates and swabs for environmental monitoring.


• A self-motivated individual who requires minimal supervision.


• Attention to detail and exceptional organizational skills.


• Basic understanding of laboratory instrumentation.


• Strong documentation skills and knowledge of Good Documentation Practices (GDPs).


• Ability to prioritize and manage multiple tasks effectively.


• Knowledge of microbiological testing and aseptic techniques in accordance with FDA, cGMP, GLPs, and USP methodologies.


• Familiarity with Laboratory Information Management Systems (LIMS) or equivalent systems.


• Effective communication skills with supervisors and peers.


• Understanding of FDA quality system regulations is preferred.