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Branch Information

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



Job Description

Position Summary:

The Microbiologist is responsible for the preparation and review of protocols, reports, procedures, investigations, training materials and other documents for the Quality departments.

Responsibilities: Essential Duties

*Work on cross-functional teams to assist with the closure of microbiology related investigations.

*Review and draft investigations and risk-assessments in support of microbiological quality compliance.

*Perform in support of investigations, CAPAs and effectiveness checks, as related to environmental monitoring and product testing.

*Compile, review and interpret statistical data and information and present metrics.

*Perform administrative duties as required in support of microbiology related investigations.

*Benchmark and apply industry best practices.

*Review, compare and update current documentation of processes and equipment functionality/design to comply with FDA's Code of Federal Regulations 21 CFR Parts 210 and 211.

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


*Bachelor's degree in Biochemistry, Biology, Microbiology, Chemistry or related scientific field is strongly preferred.

*Minimum of 3-5 years of experience in the medical device, pharmaceutical or biotechnology industry.

*Familiarity with ICH and FDA guideline, GMP regulations and quality compliance requirements preferred.

*Must have excellent technical writing skills, editing, formatting and organization skills.

*Proficient in Microsoft Office Suite.

Expertise: Knowledge & Skill Requirements

*Problem Solving - Ability to solve problems by weighing all the variables to come up with resolution.

*Accuracy - Ability to perform work accurately and thoroughly.

*Analytical Skills - Ability to use thinking and reasoning to solve a problem.

*Communication, Oral & Written - Ability to communicate effectively with others using the spoken word and in composing clear and concise messages.

*Conceptual Thinking - Ability to think in terms of abstract ideas.

*Customer Oriented - Ability to take care of the customers' needs while following company procedures.

*Decision Making - Ability to make decisions for a course of action to be taken to address a specific issue.

*Detail Oriented - Ability to pay attention to the minute details of a project or task.

*Organized - Possessing the trait of being organized or following a systematic method of performing a task.

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.