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QC Microbiology Scientist

Company: Proclinical Staffing
Location: Santa Monica
Posted on: September 17, 2022

Job Description:

Proclinical is seeking to hire a QC Microbiology Scientist located in Santa Monica, CA. As the QC Microbiology Scientist, you will be responsible for compendial and rapid microbiology laboratory methods, serves as the technical lead for evaluation, validation, and implementation of new microbiology methods and EM program.This individual will work closely with functional technical operation teams supporting the organizational vision.Job Responsibilities:

  • Author, review and execute SOPs, Protocols, Reports relating to GMP microbiology processes, test methods and related equipment maintenance Participate and support regulator audits
  • Implement, maintain, and oversee environmental monitoring program, personnel monitoring, trending and analysis
  • Oversight of microbiology programs such as growth promotion, bioburden, BacT/ALERT rapid sterility, compendial sterility, and endotoxin methods.
  • Conduct investigations regarding environmental monitoring (EM) action level excursions, and out of specifications (OOS) results for microbiological testing.
  • Identify key Microbial technologies and oversee the project from beginning to end
  • Develop and refine strategies and methodologies for microbiological testing, cleaning validations.
  • Oversee and perform the day-to-day activities related to Environmental Monitoring, product release testing, and contamination control.
  • Perform other related duties and responsibilities as assigned.Skills and Requirements:
    • PhD in a related science field and 2+years OR Master's Degree in a related science field and 6+ years OR Bachelor's Degree in a related science and 8+ years of GXP experience in the biotech and/or pharmaceutical industry specific to microbial contamination and controls.
    • Demonstrated knowledge of regulatory guidance and industry best practices
    • Demonstrated knowledge leading major investigations related to microbial contamination
    • Strong knowledge and experience in several of the following areas of competency: aseptic processing, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.
    • Expert knowledge and understanding of Microbiology principles, theories, concepts and laboratory methodologies.
    • Must demonstrate effective organizational skills and ability to manage multiple projects.
    • Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.
    • Strong knowledge of aseptic manufacturing and EM processes
    • Sit and talk or hear.
    • The employee frequently is required to use hands to finger, handle, or feel.
    • The employee is occasionally required to stand, walk, and reach with hands and arms.
    • The employee must occasionally lift and/or move up to [10] pounds.
    • Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
    • The noise level in the work environment is usually [moderate]
    • May be required to travel by plane or car [include percentage] of the time
    • This position requires working with biological and/or chemical hazardsIf you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.#LI-JC8

Keywords: Proclinical Staffing, Santa Monica , QC Microbiology Scientist, Other , Santa Monica, California

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