Johnson & Johnson
Jacksonville, FL
Shift: Full time
At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Facilities Engineering Job Category: People Leader All Job Posting Locations: Jacksonville, Florida, United States of America Job Description: Johnson and Johnson Vision is recruiting for a Facilities Management (FM) Quality /Compliance Staff Engineer , located in Jacksonville, Florida . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Facilities Management (FM) Quality /Compliance Staff Engineer provides support and direction to the Facilities department in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J J Standard of Leadership behavior model. Partners with other Departments and contractors to ensure that compliance systems are implemented in an efficient manner. Key Responsibilities: Supports the development and management of GMP compliance systems through the following activities: Carries out tasks related to the administration of site nonconformance management systems: Reviews and/or approves nonconformance investigations and their associated documentation. Manages entry of nonconformance records into the appropriate electronic system. Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate. Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate. Approves closure of nonconformance investigations on completion of the investigation and associated corrective actions. Supports the development and management of document management systems which can include: Administration of the Electronic Document Management Systems at the site Develops and applies systems and procedures related to the Electronic Document management System at the site Carries out tasks related to the management of document control in respect of SOPs and other GMP regulated documents o Supports and advises Documentation Control administration personnel, as the need arises Provides training and support to users. Generates reports and metrics from the system as the need arises. Qualifications Education: Bachelors or equivalent university degree in a Scientific/Technical subject area is required. Experience and Skills: Required: A minimum of 4 years of related work experience. Experience in a quality, manufacturing, validation or compliance role within a GMP regulated industry. Knowledgeable of FDA/EMEA regulatory requirements applicable to Medical Device and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Preferred: Experience in auditing of external suppliers, contractors and vendors. Experience in development/and or evolution of GMP systems and/or start up experience is highly desirable. Experience in a quality, manufacturing, validation or compliance role within the Medical Device and/or pharmaceutical industry. Other: General knowledge of Facility support services including: GMP cleaning, cafeteria regulatory compliance, pest control, audit readiness, critical to quality preventative maintenance. Up to 10% travel is required. Depending on evolving business needs and changing priorities, there may be occasions when additional responsibilities are required. As we move forward and adapt to, Additional responsibilities may be required based on business needs. Johnson Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503