Quality Tech II - Micro

Job Description Summary

Provides technical support at an entry level. Evaluate material and product quality by performing various procedures in the microbiology laboratory. Perform analysis on Raw Materials, Finished Products, Stability, water, and environmental monitoring samples using established analytical methods.

• Follow good documentation practices for the accurate and timely documentation of all activities.
• Receive media, reagents and solutions into 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 & .
• 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.

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

• Education
  • Bachelor’s Degree in a science related field (Chemistry, Microbiology, Biology) or an equivalent combination of education, experience, and competencies.
• Experience
  • Experience in a cGMP environment is preferred.
  • Working knowledge of instrumentation preferred.

• 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 basic principles, theories, and concepts in Microbiology.
• Basic knowledge and understanding of aseptic technique.
• Use and/or basic knowledge of industry practices and standards.

• Informing
• Customer Focus
• Listening
• Perseverance
• Organizing
• Function/technical skills
• Peer Relationships
• Comfort around Higher Management

Reports to the Supervisor 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.

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, with potential for night, weekend, and holiday work depending on the lab.

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.