QC Micro Lab Analyst

1 week ago

Totowa, United States Englewood Lab, Inc Full time
Job DescriptionJob Description
  • 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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