Staff Scientist-Microbiology/Chemistry Job in Irvine, California US
Advanced Sterilization Products, a member of Johnson Johnson's Family of Companies, is recruiting for a Staff Scientist, located in Irvine, CA
Advanced Sterilization Products (ASP) a member of the Johnson Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP has offices around the world.
The staff scientist works under minimal supervision to perform research and investigation of difficult problems where analysis of data requires evaluation of identifiable factors. The staff scientist designs, conducts and interprets experiments to support product improvement, product stewardship and business continuity related projects. The staff scientist Works in the area of Microbiology and use an application of standard microbiology principles, techniques and other related disciplines and will also work in the area of Chemistry, with considerable experience with traditional methods of chemical analysis including FTIR, HPLC, GC, titrations, pH measurement, etc.
The Staff Scientist will use knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature with a sense of urgency. The staff scientist will be working within cross functional teams to successfully resolve customer complaints, to execute CAPAs, and/or to improve product designs. The Staff Scientist will respect and apply safety rules and procedures at all times and use personal protective equipment and safety devices. He/she will promote industrial hygiene and safety matters and report incidents and damages to management whether injuries are involved or not. Participate in incident investigation, report hazards to management. The Staff Scientist will ensure a high standard of housekeeping in the work area and be a safety role-model to all employees. The successful candidate will make suggestions to improve safety at the workplace and actively participate in department EHS committee and engage in environmental awareness and participation towards ASP's environmental goals and programs
The Staff Scientist will have a duty to comply with applicable laws, regulations, standards, JJ policies and ASP policies and procedures. Examples of required areas of compliance include but are not limited to: Quality Systems (including Product Complaints, Corrective and Preventive Actions (CAPA), Internal Audits, Good Manufacturing Procedures (GMP), and Good Documentation Practices (GDP)) Sarbanes-Oxley (SOX) Health Care Compliance (HCC) Government Contract Compliance (GCC) Environmental Regulations Records Management.
Qualifications
The qualified candidate will have a Bachelors degree in Microbiology / Chemistry or related field with a minimum of 8 years experience in medical device or related industry OR; Master's degree in Microbiology/Chemistry or related field with a minimum of 4 years experience in medical device or related industry. Excellent communication skills, both oral and written, with the ability to make technical information easy to understand for a non-technical audience is required. Process Excellence experience or knowledge using Six Sigma methodologies, and CAPA experience is highly desired. Familiar with regulatory standards ISO and FDA is an asset for this position. Knowledge of 21 CFR Part 820, Design Controls, ISO 13485 and familiarity with ISO 14971 are an asset. Working experience in the area of Microbiology with use and application of standard microbiology principles and/or in Chemistry with general and analytical Chemistry is required. Experience with design experiments through the development of new methodologies is required along with the review, analysis, interpretation of data and preparing reports. Use personal protective equipment and safety devices as required. This position is located in Irvine, CA and may require 5% travel.
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