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Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
San Lorenzo, Puerto Rico, United States of America
Job Description:
Job Summary
MedTech Surgery Puerto Rico s recruiting for a QA Data Specialist, located in San Lorenzo, Puerto Rico. This role will report to Quality Team Leader, Quality Operations Leader, Quality Operations Lead or designee and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with the regulatory requirements. Supports and maintain quality data in our system, performs data analysis and performs other functions to support the Quality Assurance Department at Ethicon LLC. Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written specifications and quality standards. Main point of contact and Subject Matter Expert for the Site's Inventory Control System (ERP System, i.e. SAP) from a Quality Assurance perspective. Works closely with the ERP users, including key business functions to ensure up to date and accurate data in our ERP systems.
Key Responsibilities:
Under the direction of Quality Team Leader, Quality Operations Leader, Quality Operations Lead or designee and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Execute material hold control process in ERP systems required.
Submit changes and support implementation of changes in the documentation system.
Support the effective implementation of programs that help improve the overall quality of product and process within area of responsibility.
Support internal and external audits.
Maintain knowledge of all procedures, changes to specifications and new regulations related to the area of responsibility.
Maintain control of nonconforming raw materials, following applicable procedures.
Support Plant operations in solving quality data issues affecting the supply chain process.
Keep records of all performed tests following GDP and GMP procedures.
Perform other duties as required by department leaders as needed.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Qualifications
Education:
Associate Degree with 4 years of experience within the Quality Department in regulated industry or Bachelor's Degree (Science or Technical Field preferred) with 2 or more years of experience within Regulated Industry.
Experience and Skills:
Required:
Preferred:
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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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Our Family of Companies comprises:
The world’s sixth-largest consumer health company.
The world’s most comprehensive medical devices business.
The world’s sixth-largest biologics company.
And the world’s fifth-largest pharmaceuticals company.
We have more than 265 operating companies in more than 60 countries employing approximately 126,500 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.