Job Description

Mentor Worldwide LLC, part of Johnson & Johnson Medical Devices Companies, is recruiting for a Quality Microbiologist.

Mentor Worldwide LLC, part of Johnson & Johnson Medical Devices Companies, is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR is the only manufacturer whose silicone breast implants are made in the U.S.A. For more information, visit www.mentorwwllc.com.

The Quality Microbiologist is responsible for conducting and interpreting microbiological testing of manufactured products. Provides biological scientific support for both testing and sterilization assurance. Performs sophisticated environmental monitoring, biological indicator, growth promotion, endotoxin, and bioburden testing, and microbial identifications. Records information acquired in experiments according to established procedure. Facilitates procedures so that records and raw data are accurately retained. Summarizes and interprets data. Accountable for adhering to all quality and safety guidelines.

Key Responsibilities:
Perform lab testing, which may include environmental monitoring, sterility, bioburden, and LAL testing. Perform identification of microorganisms
Operates and maintains laboratory equipment, ensures its proper operation; operates analytical and other instruments
Ability to use, setup, and calibrate inspection equipment and software which may include, but is not limited to autoclave, water bath, pH meter, balance, data logger systems and environmental monitoring equipment
Provide support for investigation into lab out of specification results and nonconformance records, including NR creation
Prepares technical reports and other documents that record data or results
Provide technical mentorship for the execution for laboratory testing necessary to support product/process qualifications and research and development projects
Execution of conducting validation protocol and reports for test methods, equipment, and lab software
Compile and analyze test information to determine the efficiency of process or equipment and to diagnose malfunctions
Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs)
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Support audit readiness activities
Attention to detail and documentation practices is required
Willingness to work in a team environment as well as working independently

Qualifications
A minimum of a Bachelor's degree (BA/BS) from an accredited institution Microbiology or related technical field is required
Microbiology Laboratory Experience is required.
Ability to communicate effectively with co-workers and management on results and status of testing or projects
Strong analytical skills and a meticulous method of working are required
Experience with successful teamwork, influencing without authority, and working optimally on multi-functional teams is a crucial skill set
Must be able to effectively use a computer including knowledge and proficient with Microsoft Word and Excel is required
The ability to collaborate and partner with a variety of groups in a fast-paced environment with includes, but not limited to Operations, and Research and Development is required
Experience in working with an FDA and/or European regulatory environment is helpful

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Texas-Irving-3041 Skyway Circle North
Organization
Mentor Texas LP (6182)
Job Function
R&D;
Requisition ID
2105905429W