Medtronic - Santa Ana, CA

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Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description

The Microbiologist will test samples and/or review data for raw materials, solutions, utilities, in-process products and finished products to assure quality and assess microbiological levels. The Microbiologist will provide technical support and suggest solutions to technical problems of moderate complexity. This position requires strong skills in good laboratory practices and cGMPS as well as knowledge of ISO standards for terminal sterilization and microbiological methods. The Microbiologist will help define practices and policies/procedures for laboratory test methods and revise Standard Operating Procedures (SOPs) to reflect these practices. Position may support validations of new test methods, revalidations, or modifications to current methods.

Position Responsibilities

Assure all Microbiology and Quality requirements are in compliance with CFRs, ISO standards, compendial methods and specifications
Perform Microbiology testing for sterility, bioburden, Microbial Identifications, D-Values/Death Screens, Biological Indicators, LAL and Environmental Monitoring
Review Microbiology laboratory data including test results, autoclave charts, temperature charts and chemistry solutions.
Perform data review to complete sterilization and solution lot releases.
Perform Chemistry testing for solutions including pH, osmolality, concentration and ninhydrin.
Create and revise Microbiology department SOPs
Develop, perform and coordinate qualifications and validations to assure products, processes and methods comply with specifications to support operational (Manufacturing and Product Development) strategies
Provide objective microbial quality assessment
Assist in developing and coordinating quality systems to achieve continuous improvement
Write protocols as needed (e.g. test procedures and qualification and validation reports)
Participate or lead special projects as assigned

Basic Qualifications

BS degree in Biology or Microbiology
Knowledge of GMP, ISO 9001:13485 and MDD
Minimum of two (2) years experience in medical device/pharmaceutical Microbiology or sterilization and laboratory testing
Good written and verbal communication skills, communicating clearly and concisely, both orally and in writing
Proficient in Math skills, especially in Microbiology/Sterilization Science math formulas and calculations
Computer literate with focus on LIMS, Excel, Word, Power Point and Project
Good in statistical techniques
Presentation skills
Knowledge of laboratory safety

Desired/Preferred Qualifications

4 + years experience in Medical Device or Pharmaceutical industry
Strong cGMP skills and knowledge of good documentation practices

Physical Job Requirements

Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus
Light lifting of boxes for media and lab supply stocking
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.