QC Micro Lab Analyst
Found in: Resume Library US A2 - 1 week ago
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.
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