QC MICROBIOLOGY ASSOCIATE

Industry

Pharmaceuticals

Advert ID

USA_436628

Location

Irvine

Job Type

Contract

Hours

Full-Time

Salary Range

USD18.00-22.00/wk

No. of Openings

1

Branch Information

Irvine, CA - McGaw (USA) 2525 McGaw Avenue CA Irvine , CA - 92614 Phone : 949-660-2172

ContactNumber

949-660-2172

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



Requirements

Must be able to pass a 7 year background check and drug screen

Must be able to work full time hours



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

With 4 year related college degree: related experience is desirable



Desired:



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



What's in it for you?



Full time hours

Competitive wages between $18.00 to $22.00 per hour