Lab Technician IV at Medtronic in Santa Ana, California

Job Description:

Careers that Change Lives

A Day in the Life
Responsibilities may include the following and other duties may be assigned.

The Lab Technician IV 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 Lab Technician IV will provide technical support and will support projects and testing with moderate to high complexity. This position requires strong skills in good laboratory practices and cGMPS. Position may support validations of new test methods, revalidations, or modifications to current methods.

POSITION RESPONSIBILITIES:

• Comply with company's policy and procedures on maintenance of personnel hygiene and CEA cleanliness to ensure product safety.
• Assure all Microbiology and Quality requirements are in compliance with CFRs, ISO standards, compendial methods and specifications.
• Demonstrate expertise in testing in one or more of the following areas of testing: sterility, bioburden, LAL, and environmental monitoring solutions including pH, osmolality, concentration, ninhydrin, raw glutaraldehyde, and Total Organic Carbon.
• Create and revise Microbiology department SOPs
• Author technically sound protocols and reports with guidance from senior staff
• Perform microbial characterization including resistance testing (for example death screen and D value studies)
• Perform qualifications and validations to assure products, processes and methods comply with specifications to support operational (Manufacturing and Product Development) strategies
• Review and approve microbiological and chemistry data and provide assessment for data trending.
• Assist with investigation for out of specification, above alert, action level results, corrective action notification for bioburden and cleanroom excursions.
• Good written documentation practices and verbal communication skills, communicating clearly and concisely
• 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
• Statistical techniques
• Presentation skills
• Knowledge of laboratory safety
• Knowledge of GMP, ISO 9001:13485 and MDD

Must Have: Minimum Requirements

• BS degree in Microbiology, other related sciences or equivalent years of experience.
• 6+ year experience in Medical Device/Pharmaceutical; Microbiology or Sterilization and Laboratory testing.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Additional Information

• Posting Date: Sep 28, 2021
• Travel: No