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.
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**Job Function: **
Supply Chain Engineering
**Job Sub Function: **
Manufacturing Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Anasco, Puerto Rico, United States of America
Job Description:
AMO Puerto Rico Manufacturing Inc, a member of the Johnson and Johnson family of companies is recruiting for an Operations Specialist located in Anasco, 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/.
Key Responsibilities
Responsible for Initiate NRs, Investigate and respond NRs, CAPAs & Audit Observations.
Plan & execute Product Dispositions to release the product if applicable.
Perform actions according to the plan in the NRs, CAPAs and Audits Observations.
Priorities align with strategic business objectives and enables a positive customer experience.
Adheres to environmental policy, procedures, and supports department environmental objectives
Initiate NRs as required.
Perform the investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
Plan and execute product disposition.
Plan and Execute actions related to NC/CAPA & Audit Observations.
Close the investigations and Product Dispositions on time.
Identifies and escalate to Operations Investigations Lead and Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
Qualifications
Education: Minimum of a Vocational, Certificate, Technical or Associates degree required
Required:
- Minimum two (2) years of relevant professional work experience.
- Experience working in NC/CAPA & Audits Observations process, procedures and records, or equivalent experience
- Strong knowledge of FDA 21 CFR and global medical device regulations and standards is required (including but not limited to MDD, MDR Regulations, International standards ISO 13485, ISO 14971, JPAL, Canadian, and Brazil Regulations
- Excellent written and verbal communications and ability to write for external regulators, internal leaders, and others
- Demonstrated strong expertise with multiple root cause analysis and problem-solving methodologies
- Able to communicate clearly with both external regulators and internal staff at all levels of the organization
- Ability to critically and logically review and analyze documentation
- Ability to understand how multi-site and stakeholder relationships affect processes
- Ability to work independently on work assignments with minimal oversight
- Must be computer literate in E-Mail, word processing and spreadsheets
- Must be detailed oriented and have the ability to develop and meet deadlines, and be able to delegate and follow-up
Other:
- Ability to read, speak, and write Spanish and English is required
- May require up to 10% domestic and/or international travel to other sites and locations
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:
Accelerating, Analytical Reasoning, Coaching, Communication, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Schedule, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy