Operations Support Specialist

Johnson & Johnson•Anasco, PR

About The Position

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 . 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. 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 Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Business Unit manufacturing process. Responsible for overseeing the Non Conformance Report (NRs) and Corrective action and preventive action (CAPA) and Audit Observations.

Requirements

Bachelors Degree is required.
Bachelors Degree in Science or Business Administration is preferred.
Minimum of 4 years of experience in NC/CAPA & Audits Observations process is required
Regulated medical device operation preferred.
Experience in a quality role within the manufacturing industry preferred.
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
Bilingual (Spanish & English)
Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.
Proficient in the preparation of technical reports and presentations.
Strong communication and interpersonal skills.
Requires good negotiation skills.
Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.
Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
May requires working / visiting all shifts and working irregular hours.

Nice To Haves

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

Responsibilities

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.
Identify and escalate to Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
Review and analyses quality trends with the manufacturing team.
Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
Provide guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.
Provide leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
Lead investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities the implementation process.
Analysis of data and based on the trends recommends actions for process, equipment and system improvement.