Manufacturing and Production

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Branch Information

Irvine, CA - McGaw (USA) 2525 McGaw Avenue CA Irvine , CA 92614

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Job Description

Position Summary:

Performs routine functions and analysis (dependent upon experience) as required by the specific laboratory requirement in compliance with cGMP specifications.

Responsibilities: Essential Duties

*Collect and organizes data for Microbiology identification trend

*Responsible for routine environmental monitoring, finished product, stability, and utilities sampling and testing under close supervision of senior staff

*Interpret and apply specifications and operating procedures when carrying out monitoring and testing responsibilities

*Review verification of environmental monitoring, raw materials, and finished product data sheets

*Responsible for the general cleanliness and appearance of respective lab by keeping laboratory equipment, supplies, and overall environment in good operational status

*May prepare media reagents, testing materials, and equipment as required

*Records data in controlled notebooks, controlled data sheets, validated spreadsheets, and completes analysis report forms

*May be required to work on special projects such as investigations, and non-routine testing

*Maintains neat and legible records

*Promptly and accurately inputs data into Sapphire LIMS

*Follows cGMPs, GLPs, SOPs, USO, and FDA guidelines in all appropriate functions and notifies Supervisor, Exempt, or Lead of any observed discrepancies in laboratory or plant operations

*Evaluate and trend environmental monitoring data

Responsibilities: Other Duties

*Other duties assigned

Expertise: Qualifications - Experience/Training/Education/Etc.


*High graduate or equivalent

*Without 4 year related college degree: 3-5 years related experience

*With 4 year related college degree: related experience is desirable


*BS degree in Microbiology or related field

Expertise: Knowledge & Skill Requirements

*Become proficient in environmental monitoring techniques specific to Duplex Microbiology

*Become proficient in finished product and raw material testing as required, i.e. Sterility, LAL, and Electronic PM

*Learn to write and edit environmental monitoring and laboratory procedures dependent upon experience

*Become proficient in Microbial techniques such as Gram staining, kilutions, filtering, and evaluation of plates and test tubes for microbial growth

*Initiate and/or conduct the investigation for non-conformance of routine testing specifications dependent upon experience

*Understanding of aseptic laboratory and manufacturing processes

*Knowledge in CFR, USP, cGMP, GLP, and other FDA regulations

*Knowledge and experience in microbiology and sterilization validations

*Ability to use Microsoft Office (Word, Access, PowerPoint, Excel)

*Excellent verbal and written communication skills

*Excellent organizational skills with the ability to adapt to changes

*Knowledge of LIMS

Physical Demands:

*While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk or bend and twist. The employee must occasionally lift and/or move up to 20 pounds.

Work Environment:

*The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.