Overview
Quality Specialist I Jobs in Piedmont, SC at Poly-Med, Inc.
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
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Anasco, Puerto Rico, United States of America
Job Description:
About Vision
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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for Senior Analyst, Quality Assurance to be located at Añasco, PR.
The Senior Analyst, Quality Assurance establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.
Key responsibilities:
Monitors and tracks all sources of quality detractors utilizing the service database and complaint database.
Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations.
Develops solutions to database problems of moderate scope and complexity.
Writes and assists others in writing standard operating procedures.
Generates and identifies significant trends. Regularly reports them to management and appropriate cross functional teams.
Provides support to NC investigators to assure sound and complete investigations are developed and approved.
Ensures verification and closure of Product Disposition records.
Provides advanced technical assistance in the use of information mapping technology.
Provides support to product review and release functions.
Generates moderately complex statistical summaries.
Provides support to good manufacturing practice auditing.
Provides support on activities, documents and records requiring Quality review and/or approval as deemed necessary
Liaises with Operations and Quality & Process Engineering to ensure consistent alignment, implementation and rollout of new processes and procedures.
Conducts root cause and investigation analysis to improve product and processes.
Serves as CRB chairperson
Reviews and approves Investigation Requests pertaining to Site complaint investigation for completeness and compliance to requirements.
Participate in Rapid Response Meetings related to product complaints.
Coordinate activities and assignment of Product Investigation or Failure Investigations to complaints investigators.
Support site QA Management in activities related to quality escalations (RMB’s, QRB, etc)
Qualifications
Education
A minimum of a Bachelor’s degree is required.
Experience and Skills
Required:
A minimum of 2 years of experience in Quality Assurance functions within the Pharmaceutical or Medical Device Industry.
Able to read, write, and speak English and Spanish.
Knowledge and/or experience in Microsoft Office tools (Word, Power Point and Excel).
Basic knowledge of applicable US & non-US applicable regulations and standards (For example 21 CFR 820, ISO13485, European Medical Device Directive)
Preferred:
Knowledge in GDP and GMP
Other:
This position may require up to a 10% of domestic and/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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
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Title: Quality Specialist I
Company: Poly-Med, Inc.
Location: Piedmont, SC
