• Microbiology Supervisor

    J&J Family of Companies (Gurabo, PR)


    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 https://www.jnj.com

    Job Function:

    Quality

    Job Sub** **Function:

    Quality Control

    Job Category:

    People Leader

    All Job Posting Locations:

    Gurabo, Puerto Rico, United States of America

    Job Description:

    About Innovative Medicine

     

    Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

     

    Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

     

    Learn more at https://www.jnj.com/innovative-medicine

     

    Johnson& Johnson is recruiting for the Quality Control Department a Microbiology Supervisor to be located in Gurabo, Puerto Rico.

    Key responsibilities:

    + Assure all laboratory tests are performed in accordance with internal and external regulations and policies and consistent with supply chain cycle time goals.

    + Approve all testing of raw materials, products and utilities according with internal and compendia specifications.

    + Provide support to the microbiological aspects of the manufacture, validations and projects related to the parenteral area.

    + Support equipment qualification activities and new technology introduction.

    + Provide technical knowledge to make decisions related to product quality from the microbiological standpoint during manufacturing processes as needed.

    + Performs Investigations and risk assessments when questionable microbiological results have been generated. Assure the compliance to all quality control policies, procedures, and systems to ensure the timely release of high-quality products of the supply chain process.

    + Coordinates laboratory activities according to the supply chain needs.

    + Develop and present metrics to support manufacturing microbiological data evaluation and trending.

    + Participate in external and internal cGMP audits.

    + Support laboratory projects to assure compliance, costs reduction, laboratory operations efficiency and capacity's increase.

    + Approve of laboratory tests and environmental monitoring data.

    + Develops and reviews all laboratory procedures and verifies its compliance with internal and external requirements.

    + Works on the assessment of suspect results or process/method deviations to assure the data integrity and proper and complete documentation.

    + Provide technical support to manufacturing investigations and projects as needed.

    Qualifications

    Education:

    + A minimum of a Bachelor’s degree in Science is required; a minor in Microbiology, Biology or Biotechnology is preferred.

    Experience/Skills:

    + Proven experience in Quality Control is required.

    + A minimum of two (2) years of experience in a Microbiology Laboratory GMP environment is required.

    + Background in solids and/or aseptic processing required.

    + Experience with MS Office (Word, Excel, PowerPoint) and in laboratory data entry systems (e.g. eLIMS) is preferred.

    + Knowledge in method validations and transfers required.

    + Understanding of USP, EP, JP and FDA and International Regulatory Requirements is required.

    + Fluent in Spanish & English (writing and speaking) is required.

    + Availability to work various work schedules, which may include 1st and/or 2nd, shifts, including weekends and holidays.

     

    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 of the Rehabilitation Act.

     

    Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.