QC Micro Lab Analyst

• Support process validation/qualification, equipment/instrument calibration and verifications, including the review of logbooks, instruments, media, etc.
• Review testing with R&D, schedule workload for samples from mfg and pdn
• Problem solving with colleagues regarding OOS results, discuss additional testing, operation of equipment, meeting to share ideas. CAPA responsibility
• Assist in drafting NCRs prior to submission to Lab Manager, check calculations, possible cause with review of batch records
• Assist the Microbiologist/Supervisor in the review of workload priority and staffing requirements with Manager to assure organization priorities are met and communicate priority releases
• Assist with quality and environmental health and safety audits
• Maintain experience with Incubators, Laminar Hoods, Bio Safety Cabinets, Autoclaves, Simple and Compound Microscopes, Colony Counter, DI Water Units, Media, Cultures, Standards, Sterilizers, etc.
• Assist in scheduling maintenance services for many different types of Lab equipment
• Interact with customers, other employees and external contractors
• Compliance to Data Integrity requirements
• Assist with investigation of quality issues such Out of Specification, Out of Trends, etc.
• Familiarity in Aseptic techniques and Sterility
• Familiar with Gram staining, endospore staining techniques, catalase testing, oxidase testing, etc.
• Micro identification techniques is a plus (e.g. Vitek, DNA sequencing [PCR], etc.)
• Familiar with Blood-borne pathogens
• Familiar with the principles of immunology, virology and microbiology
• Assist in the training of new micro lab personnel
• Assist in the management of chemical hygiene program for the laboratory
• Assist in the management of media, glassware, chemical and consumable stocks
• Maintain USP/NF Compendia, FDA BAM, AOAC, PCPC Methods, ISO Standards
• Familiarity with US FDA 21CFR Part 210 & 211 (Drug Product) and Cosmetic GMPs is required
• Perform other functions as may be requested by Supervisor

Requirements

• Associate Degree or Bachelor’s degree in Biological Sciences or related life science field, or Engineering or Chemistry
• Knowledge in GMP, GLP, Root Cause Analysis & Corrective Action Planning Tools
• Knowledge of micro challenge testing is a plus
• Knowledge of Environmental Monitoring is a plus
• Micro Lab experience with Incubators, Laminar Hoods, Bio Safety Cabinets, Autoclaves, Compound Microscopes, Colony Counter, DI Water Units, Media, Cultures, Standards, Sterilizers, micro identification techniques, flaming technique, etc.
• Familiarity with Clean room environment (e.g. Class 7, 8, etc.) is a plus
• Good interpersonal and written communication
• Flexible, ability to multitask and designate
• Good Organizational Skills
• Ability to Teach/ Train employees
• Good Math skills required

Benefits

• Medical, dental, and vision insurance
• Life insurance 100% paid by the company
• 401(k) matching after 6 month.