Quality Technician Junior

Job Title: Quality Control Technician Junior

Job Location: Saint Louis, MO

Job Type: Contract

Preferred Visa: USC, GC

SUMMARY OF POSITION

Provides technical support at an entry-level. 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 water testing for all Mallinckrodt Sites
• 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
• Receive and send packages from various MNK sites
• Order supplies needed for daily activities

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• LIMS entry of data
• Use of analytical balance, pH Meter, TOC Analyzer, Kinetic Turbidimetric Analyzer, Autoclave
• Maintain instrument readiness

MINIMUM REQUIREMENTS:

Education: Bachelor's Degree in a science-related 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 8-hour shifts, potential for night, weekend, and holiday work depending on the lab

MATERIALS , MARKETING , ANALYTICAL BALANCE