Job Title: Quality Technician Junior
Job Location: St. Louis MO (Onsite)
Job Type: Contract (6 Months with extension)
Description:
SUMMARY OF POSITION:
Provides technical support at an entrylevel. Will evaluate material and product quality by performing various procedures in the microbiology laboratory. This individual performs analysis on Raw Materials Finished Products Stability water and environmental monitoring samples using established analytical methods.
ESSENTIAL FUNCTIONS:
- Follow good documentation practices for the accurate and timely documentation of all activities
- Receive media reagents and solutions in the laboratory
- Run autoclave cycles routinely
- Archive data and files per site procedures
- Perform routine housekeeping and cleaning
- Create samples in LIMS and send test results from LIMS to customers
- Perform product bioburden testing on incoming raw materials swabs and finished products
- Ability to perform gram stain and interpret data
- Perform environmental monitoring in production
- Perform microbial limits testing as per USP 61 & 62.
- Perform endotoxin testing by kinetic methods
- Perform water sampling in various production areas
- Follow site HSE Policies and perform GMP walkthroughs
- Assist with establishing & maintaining safe work standards in the lab
- Peer review and approve some levels of work
- Order supplies needed for daily activities
DEPARTMENT SPECIFIC/NONESSENTIAL FUNCTIONS:
- LIMS entry of data
- Use of analytical balance pH Meter TOC Analyzer Kinetic Turbidimetric Analyzer Autoclave
- Maintain instrument readiness
MINIMUM REQUIREMENTS:
Education: Bachelors Degree in a sciencerelated field (Chemistry Microbiology Biology) or equivalent combination of education experience and competencies.
Experience: Experience in a cGMP environment is preferred. Working knowledge of instrumentation is preferred.
Preferred Skills/Qualifications:
- Use of analytical balance pH Meter TOC Analyzer
- Performs purified & DI water testing as required by USP
- Performs plant environmental monitoring
- Basic computer skills and familiarity with Microsoft Office Suite
- Substantial acquaintance with and understanding of the application of basic principles theories and concepts in Microbiology
- Basic knowledge and understanding of aseptic technique
- Use and/or Basic knowledge of industry practices and standards
- Skills/Competencies: Informing Customer Focus Listening Perseverance Organizing function/technical skills Peer Relationships Comfort around Higher Management
ORGANIZATIONAL RELATIONSHIP/SCOPE:
Reports to the Supervisor of Quality Microbiology. Contacts involve matters of moderate importance to the organization and include R&D Marketing Production Superintendents Production Engineers Production Lead Operators Logistics Safety and DEA. Infrequent customer contacts on routine matters.
WORKING CONDITIONS:
- 80% Laboratory exposure to plant products solvents and reagents some of which are hazardous or potent compounds
- 20% Office environment
- Required to work 8hour shifts with the potential for night weekend and holiday work depending on the lab
MATERIALS , MARKETING , ANALYTICAL BALANCE