Quality Assurance Specialist

J&J Family of Companies; San Lorenzo (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Assurance Specialist to uphold product quality and regulatory compliance. The role supports OPCERT, data analysis, and process improvements within Ethicon LLC's operations.

Responsibilities include material inspection, training coordination, audits, and ensuring adherence to QSR and ISO standards. English and Spanish language proficiency is required, with overtime availability as needed.

Qualifications

• Minimum Associate Degree required.
• At least four years in regulated manufacturing.
• Two years in Quality Assurance preferred.
• Bilingual English/Spanish communication required.

Responsibilities

• Handle non-conformant material and hold processes.
• Maintain control of material in hold cage and manage stop shipments.
• Lead Stop Shipment processes in distribution/interplants.
• Coordinate OPCERT program training for associates.

Skills

Analytical Reasoning

Business Behavior

Compliance Management

Continuous Improvement

Controls Compliance

Data Analysis

Execution Focus

ISO 9001

Persistence and Tenacity

Quality Control

Quality Control Testing

Quality Standards

Quality Systems Documentation

Report Writing

Sample Testing

Technologically Savvy

Education

Associate Degree

Job description

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 jnj.com (https://www.jnj.com) .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Job Category:

Professional

All Job Posting Locations:

San Lorenzo, Puerto Rico, United States of America

Job Description:

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

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on your journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Quality Assurance Specialist.

Purpose : Reports 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 OPCERT program, performs data analysis to support process improvements and decision making 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. Support cost improvement projects at plant level and prepare reports (using the computer system) as assigned.

You will be responsible for :

• Handling of non-conformant material or potential non-conformant material.
• In charge of maintaining all material inside the hold cage on control. Placing and removal of material on hold.
• Lead of Stop shipment process for material in the Distribution Centers or Interplants. Place and remove material on hold as applicable.
• OPCERT PROGRAM:
• Coordinate and provide training to associates on inspection and disposition of product.
• Update and maintain training material for inspection and disposition of product.
• Coordinate and perform practical evaluation for inspection and disposition to associates.
• Update and maintain material for practical evaluation and auto-monitoring.
• Verifies completion of operator certification requirements for associates and request operator certification.
• Perform audits and support the internal audit program.
• Maintain knowledge of all procedures, changes to specifications and new regulations related to the area of responsibility.
• Support associates on defect awareness and specification requirements.
• Data Analysis, Process Improvements and Decision Making:
• Exercise initiative, leadership and decision making to solve quality-related issues with other departments’ organization members and other Ethicon sites’ organization members.
• Perform data analysis and recommend disposition of material.
• Use of Statistical Process Control knowledge to make decision on the acceptance/rejection of the product/process.
• Perform batch record review for product release.
• Evaluate and make decisions on day-to-day manufacturing QA related issues.
• Participate in non-conformances’ investigations and root cause analysis.
• Evaluate and approve product control and disposition to determine if product is according to the requirements and Quality Systems Regulations.
• Responsible for coordination of hold material and track and report of hold trends.
• Support Engineering and QA Departments in projects and validation activities.
• 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.
• Utilize quality and statistical tools to recommend process improvements.
• Train new Quality Specialist at the manufacturing area and QA Specialist duties and responsibilities
• Perform particle count monitoring, per applicable procedures.
• Coordinate dose audit monitoring samples, per applicable procedures.
• Support Finished Goods Lab as back up, when necessary, for specific duties of QA Finished Goods Technician as required.

Qualifications / Requirements:

• A minimum of an Associate Degree is required.
• A minimum of four (4) years of experience in the regulated manufacturing industry is required.
• At least two (2) years of experience in Quality Assurance is preferred.
• 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.
• Knowledge of QSR’s and ISO Standards is required.
• ASQ CQT is preferred.
• ASQ CQA is preferred.
• Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

LI-Onsite

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy