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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

Johnson & Johnson is currently seeking a Quality Microbiology Supervisor, Laboratory to join our outstanding team in San Lorenzo, Puerto Rico.

In this role under the direction of the Quality Laboratory Leader and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with regulatory requirements, you will supervise day-to-day activities of the Quality Control Laboratory Technicians, in accordance with QSR and Ethicon written specifications and quality standards. You will be responsible for establishing and overseeing the laboratory and/or equipment, providing a variety of testing services and technical support to customers and supporting Enterprise-wide initiatives that enhance the overall level of compliance!

Key Responsibilities:

• Supports Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.).
• Coordinate the most efficient use of laboratory resources for the analysis and disposition of raw materials, in-process, stability samples and final products.
• Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices.
• Monitor the performance of the CME (Controlled Manufacturing Environment), including but not limited to Product Bioburden monitoring.
• Coordinates and monitor the Plant’s Dose Audit Program.
• Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes. Facilitate the design transfer process between corporate and plant environments.
• Directly supervises QA Laboratory Technicians and QA Coordinators as required and trains, develops and evaluates subordinates.

Qualifications

Education:

• A minimum of a Bachelor’s degree or University equivalent in Scientific discipline is required, a concentration in Biology or Microbiology is preferred.
• A Master’s Degree is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of experience in a regulated manufacturing industry.
• A minimum of three (3) years working in a Supervisory role in a laboratory.
• Must be proficient in Microsoft Office Suite including Word, Excel, and Outlook.
• Must be proficient in Minitab
• Experience with Nonconformance, CAPA, Audit Observations, and initiates and maintains interplant communications of quality issues.
• Applies tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required.
• Prior People Leader experience.

Preferred:

• Knowledge of ISO14001 & OSHAS 18001 regulations.
• Experience supporting internal and external audits (supplier, contractor, contract laboratory) and ISO 9000, as well as assessments of technical, engineering, operations, & quality related areas.
• LIMS experience preferred

Other:

• This position will be located in San Lorenzo, Puerto Rico and may require up to 10% domestic or international travel.

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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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