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Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Business Enablement/Support

All Job Posting Locations:

San Lorenzo, Puerto Rico, United States of America

Job Description:

Job Summary

Reports to the Quality Team Leader or Designee, with the objective of maintaining high Quality Standards for Product Quality Control and operations compliance with regulatory requirements. Conducts routine physical inspection procedure to in-process material, as well as finished goods, as needed. Inspection involves the use of skilled specifications and established quality standards. Performs audits to ensure product and processes comply with requirements.

Responsibilities

Under the direction of the Quality Team Leader or designee and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will require someone who:

• Maintains high Quality Standards for Product Quality Control and operations compliance with regulatory requirements.
• Conducts routine physical inspection, testing, or evaluation to ensure quality of products according to current specifications/procedures.
• Performs product and process audits.
• Notify any product or process non-conformance and escalates as appropriate.
• Segregates and inspects Finished Goods samples and Retain Samples according to the requirements. Delivers samples to Finished Goods QA Lab if needed.
• Performs data analysis and executes final disposition of the material as required.
• Performs batch records review accordingly with compliance requirements and complete record retention process.
• Maintain knowledge of all procedures, change to specifications and new regulations related to their areas of responsibility.
• Ensures on-time completion of assigned trainings.
• Support associates on defect awareness and specifications requirements.
• Support validation activities as required.
• Train new Technicians in Quality Assurance duties and responsibilities as required.
• Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
• Perform environmental particulate monitoring as required.
• Comply with the OPCERT program for the certification of manufacturing associates.
• Evaluate and approve control and disposition of material to determine if it is according to the requirements and Quality System Regulations.
• Responsible for reporting material on hold.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed.

Experience and education

• High School Diploma and one (1) year of experience in a regulated industry is required; or
• Bachelor’s Degree in a technical or science field.
• One (1) year of Quality assurance experience is preferred.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

• Knowledge of QSR's and ISO Standards.
• PC literacy including MS Office and use of other software and applications is required.
• Verbal and written communication skills in English and Spanish are required.

Other Position Requirements

• Personal Protective Equipment (PPEs): Safety shoes, safety glasses, reflective vest, etc.
• This position is for 3rd shift. However, availability to work overtime, weekends and holidays is required as per business needs.
• On Call ( Call in for work ) if required.
• Ability to work in stressful/fast paced environment.
• Ability to work and interact with co-workers to accomplish company goals in a team environment.
• Analytical/Problem Solving Skills.
• 10% travel requirement between Ethicon Locations, Domestic and/or international travel is required.

Company disclaimer:

Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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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