The Executive, Quality Control plans, coordinates, and performs routine and complex microbiological testing in compliance with laboratory test methods and procedures to support the manufacturing and timely delivery of products to customers. The individual also executes activities of Quality Control, Microbiology section to ensure continuous production of products consistent with established Quality & Regulatory standards.
Key Responsibilities:
- Perform applicable compendia testing, microbiological test method validations/verifications.
- Conduct microbiology testing and report reviews after thorough training under supervisor guidance.
- Initiate and participate in investigations for non-conforming laboratory test results, incidents, and out of specifications (OOS)/out of trends (OOT).
- Apply troubleshooting methodology to rectify instrument problems for smooth functioning of microbiology tests and microbial evaluation.
- Perform microbiological tests including bioburden test, water tests, MLT, bacterial endotoxin tests, microbio-stasis tests, sterility tests, GPT, environmental monitoring, personnel monitoring, specified MO’s tests, and enumeration using aseptic techniques.
- Prepare media and manage media/chemicals inventory.
- Plan and execute activities related to microbiological SOP preparation, protocols, reports preparations including instrument validations, area qualifications, microbial evaluation of sterilization process, hold time studies of sterilized media, cleaning and disinfectant validations, and sterilized garments.
- Operate in accordance with current GxPs, documenting, testing, and maintaining accurate laboratory records. Comply with all training requirements.
- Support and execute activities related to microbiology projects, change controls, and effectiveness monitoring.
- Perform calibrations, validations, and annual/maintenance of laboratory instrument life cycle management according to current SOPs.
- Assist in various other duties contributing to the organization and function of the laboratory as assigned by supervisor.
- Ensure personal and company compliance with all local and company regulations, policies, and procedures for health, safety, and environmental compliance. Coordinate and support in biohazard safety and management.
- Support and coordinate in microbiology data record management, timely archival, and retrieval.
- Ensure all-time audit readiness and 5S in microbiology, quality control lab.
- Manage test method validation and test method life cycle management for microbiology test methods.
- Ensure proper execution of procedures and practices for audit readiness and coordinate activities related to internal and external audits.
- Support in formulating and meeting microbiology objectives and coordinate objectives and priorities with cross-functional teams (CFT).
- Trend and analyze statistical data related to microbiology activities to determine present standards and establish proposed quality and reliability expectancy.
- Carry out duties in compliance with all regulations and guidelines including MDR and FDA. Comply with all company and site policies and procedures. Follow all applicable aspects of the site environmental management system.