QC Micro Lab Analyst

Found in: beBee S US - 1 week ago

Totowa, United States Englewood Lab Inc Full time
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.

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