Microbiologist

Job description

POSITION DESCRIPTION:

The Microbiologist coordinates daily activities in the Microbiology/Analytical Laboratory including routine and non-routine testing, validation testing and projects. Performs annual and periodic reviews of laboratory documents for compliance with corporate and local requirements as well as regulatory standards.

Reviews and approves validation protocols. Identifies and develops areas for increased efficiency and other improvements within the Laboratory. Trends and reports Laboratory metrics as specified in corporate and local procedures. Perform investigations into root cause for laboratory errors, nonconformances and CAPAs. Provide guidance for team members for execution of goals.

POSITION RESPONSIBILITIES:

•Utilizes microbiology/analytical techniques to perform routine testing, maintenance, and calibration of instrumentation.
•Performs routine sterility testing in an isolator system.
•Prepares all solutions and reagents required for testing; checks expiration dating of reagents and media before use.
•Performs environmental sample evaluation.  Trends and reports environmental and product testing data
•Coordinates daily activities and non-routine testing in the Micro/Analytical Laboratory.
•Actively support and participate in new product development activities.
•Participate in the development and improvement of the manufacturing processes for existing and new products.
•May lead in the development, review and approval of laboratory process, test method, and equipment validation/qualifications (IQ, OQ & PQ).
•Key contact for suppliers for new process development, quality issues and process improvements for assigned projects related to the laboratory.
•Review/approve change control documentation
•Participate in continuous (breakthrough) improvement activity
•Trends and reports Micro/Analytical Laboratory metrics                                          
•Provides feedback on performance metrics laboratory staff
•Mentors laboratory personnel and provides feedback and guidance
•Demonstrates proper initiation of Quality Notification/nonconformance documentation.
•Demonstrates proper review and completion of OOS and Environmental excursion evaluations (EEE).
•Performs trouble-shooting/problem solving activities related to instruments and/or other issues.
•Performs daily data audits and release of data.
•Coordinates activities with vendors for instrument PMs and calibrations.
•Coordinates safety inspections of laboratory.
•Accurately completes required paperwork and reports in accordance with Good Documentation Practices (GDP) and SOPs.
•Uses appropriate laboratory safety procedures and PPE to properly dispose of biohazard/chemical waste and when performing other functions.
•Designs and executes Laboratory studies or validation protocols as required.
•Performs investigations and CAPAs.
•Ensures cleanliness of the overall laboratory, and works to resolve any supply inventory or equipment issues.
•Aids in guidance of team members for daily tasks as well as for goals.
•Behaves ethically in all situations and reports or challenges unethical behavior of others.     
•Reviews SOPs and revises as needed, submits in AGILE.
•Follows cGLP, cGMP, ANSI, AAMI, ISO, FDA, USP and other applicable guidelines to the testing of class II medical devices and tissue products
•Perform other job-related tasks as required by Supervisor/Management

 
Physical Job Requirements

The physical demands described here 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 sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls.  The employee is occasionally required to reach with hands and arms.  The employee must occasionally lift and/or move up to 15 pounds.  Specific vision abilities required by this job involve normal vision.

Medtronic Overview

Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with 85,000+ employees in more than 160 countries.

EEO Statement

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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Desired profile

BASIC QUALIFICATIONS:
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

REQUIRED EDUCATION:  
Bachelor’e dgree in Microbiology or related technical field

 

REQUIRED YEARS OF EXPERIENCE:  

2+ years of experience with a Bachelor’s degree

Must be cross-functionally trained in all Laboratory Technician level duties.

Must have good basic knowledge of all Laboratories (Microbiology, Chemistry, and Isolator) and SOPs.

 

DESIRED/PREFERRED QUALIFICATIONS:
•Demonstrates good laboratory/aseptic technique and practices. 
•Quality experience in an FDA-regulated laboratory environment preferred
•Experience successfully interfacing with government and accreditation agencies (FDA, ISO, AATB) and writing regulatory filings, responses and other documents required in a regulated environment
•Strong communication skills, both oral and written
•Good interpersonal skills
•Skillful in formulating strategies, tactics and action plans to achieve results
•Strong focus on developing an organizational culture that fosters teamwork
•Ability to work in a fast paced environment
•Ability to effectively influence key decision makers
•Ability to work well under pressure and maintain positive, enthusiastic attitude