QC Lab Trainer

Location: Los Angeles Consulting
Department: Azzur of CA, LLC

Job Description

Key Responsibilities will include the following, the verbiage needs a little tweaking to align with our usual JDs. It's time sensitive so I would like to place a priority on this effort :) 
  • Microbiologist with experience in the Pharmaceutical, Sterile, Non-Sterile Drug Products and Cosmetic and manufacturing industry
  • Thorough knowledge of FDA CGMPs, USP Microbiological methods including <51>, <61>, <62>, <71>, <85>, <1072>, <1116>, <1117>, <1231>; 21 CFR 210, 211, ISO 14644-1, ISO 14644-2, ISO 14698-1, ISO 14698-2, ISO 11737-1
  • Excellent aseptic and sterile techniques
    • Assist with ILT for new Lab Technicians on proper aseptic techniques, microbiology test methods, and proper use of laboratory equipment and instruments.
  • Develop and revise training program to include comprehensive on the job training
  • Implement and continuously improve quality systems to ensure compliance with testing SOPs and specifications. Utilize regulatory and quality guidelines such as FDA, GLP, QSR, cGMP, USP, and CDR as guidance for these systems
  • Efficient leadership skills
    Teamwork oriented, collaborative and respectful
    Creative problem-solving skills and excellent communication skills
  • Management of QC Microbiology training program, including Aseptic process qualification and gown qualification programs. Include reporting.
Experience
  • B. Sc / Masters / PhD in Microbiology. Related coursework: Microbiology, Cell Biology, Virology, Molecular Microbiology, Immunology, Cell Metabolism, Biochemistry
  • 7 - 10 yrs experience
  • Experience with QC assays
    Experience with Micro assays (LAL, Bioburden, pH, TOC, conductivity)
    Experience with environmental monitoring (viable and nonviable testing)
  • Must demonstrate the ability to effectively coach, mentor, and motivate lab technicians , resulting in a high-performing team with a focus on results and task completion in support of operational goals

Perform QC Trainings (focus will be on micro but might also
include biochem assays)
Running Training Reports
Assist in the new employee on-boarding process
Perform ILT for QC Lab Orientation

Qualifications:
Training background is ideal
Experience with QC assays
Experience with Micro assays (LAL, Bioburden, pH, TOC,
conductivity)
Experience with environmental monitoring (viable and nonviable
testing)


Apply Now

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