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Quality Assurance Specialist, Microbiology
2 months ago
We are seeking a highly skilled Quality Assurance Specialist, Microbiology to join our team at FUJIFILM Diosynth Biotechnologies. The successful candidate will be responsible for supporting and maintaining quality control microbiological functions for new and existing GMP manufacturing operations.
Key Responsibilities- Environmental Monitoring: Collects and performs non-viable, viable air (active and passive) and surface monitoring and personnel monitoring to support routine environmental monitoring, in-process environmental monitoring, process simulation, aseptic operator qualification and gowning qualification.
- Sampling and Testing: Performs sampling and testing of GMP utilities such as compressed gases.
- Data Management: Documents Environmental Monitoring sampling using Laboratory Information Management System (LIMS) and reviews Environmental monitoring raw data generated by LIMS.
- Microbiological Assays: Executes microbiological assays such as bioburden, endotoxin, gram stain, mold identification, growth promotion and plate enumeration.
- Quality Control: Supports EM data management including data entry, data verification, data download, generation of crystal reports from LIMS to support data trending.
- Maintenance and Calibration: Performs routine maintenance including support of calibration and sanitization of lab equipment and lab spaces.
- Equipment Qualification: Supports QC equipment qualification including implementation of new methods.
- Procedure Development: Revises procedures and forms with guidance from supervisors.
- Inspections and Audits: Supports internal and external inspections and audits.
- Reporting: Generates Desigo reports for non-viable particulates testing during in-process environmental monitoring.
- Equipment Calibration: Tracks and supports the calibration of EM equipment such as Climet and SAS.
- Work Orders: Generates Work Orders for equipment, data entries for material ingress.
- Isolate Shipping: Coordinates the shipping of isolates for microbial identification.
- Special Projects: Performs special projects as assigned.
- Education: Bachelor's degree in microbiology, Molecular and Cellular Biology, Biochemistry, or Biology with 0-3 years of experience; or Associate degree with 4+ years of direct laboratory experience; or High school diploma with 6+ years of experience.
- Experience: Quality Control experience in the pharmaceutical industry supporting cGMP manufacturing including site qualification and utility validation preferred.
- Skills: Direct experience is highly desirable in environmental monitoring, personnel monitoring, sterile gowning, and aseptic process control in accordance with ICH, USP and FDA guidelines.
- Communication: Must possess excellent verbal and written communication skills, good interpersonal skills.
- Regulatory Knowledge: Direct experience is highly desirable in regulatory inspections.
- Cell Therapy Experience: Experience in cGMP for cell therapy testing is a plus.
- Physical Requirements: Subject to extended periods of sitting and/or standing in a laboratory and classified room environment. Ability to lift 50 lbs. and to work in controlled space laboratory required.
