Ethicon LLC (a member of Johnson & Johnson Family of Companies) is currently seeking a Quality Supervisor, Laboratory to join our outstanding team in San Lorenzo, Puerto Rico!
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/.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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:
- 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 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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.