Sr. QC Analyst, EM/Microbiology
- Employer
- Vaxart, Inc.
- Location
- South San Francisco, CA
- Start date
- Nov 22, 2021
View more
- Discipline
- Quality, Quality Control, Science/R&D, Microbiology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
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Summary:
The Sr. QC Analyst, EM/Microbiology is responsible for supporting the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacture for both At Rest and In Operation conditions. This candidate will also be responsible for all activities associated with environmental monitoring, microbiological testing, raw material sampling and ID testing, and other activities as assigned by supervisor.
Responsibilities:
- Updates daily, weekly, and monthly testing schedules.
- Performs Environmental Monitoring (EM) and Raw Material (RM) sampling and testing.
- Coordinates delivery of and tracks samples tested by Contract Testing Laboratories (CTL).
- Scans and archives QC documents and approved data.
- Performs visual inspection of laboratory and equipment
- Maintains laboratory cleanliness and organization in accordance with cGMP standards
- Coordinates equipment maintenance/calibration.
- Performs data entry for tracking & trending of sample management and lab log reports.
- Manages QC sample inventory and retains sample inventory.
- Analyzes and documents results of test methods following cGMP guidelines for reporting test results.
- Revises and authors SOPs under the direction of management
- Supports execution of method validation protocols
- Leads internal projects to support departmental initiatives
- Coordinates with Quality Assurance to Initiate deviation investigations
- Trains others to perform EM/RM sampling and testing
- Reviews laboratory logbooks and laboratory control documents
- Conducts audits and assessments of manufacturing operator sampling technique
- Assumes additional responsibilities as needed
Requirements
- BA/BS degree in a scientific discipline.
- 5 years of relevant industry experience.
- 3-5 years of prior microbiology test method development and/or QC Microbiology/Environmental Monitoring experience.
- Experience leading projects and identify and implementing process improvements
- Weekend work may be required with a work schedule of 5X8 hours or 4X10 hours
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