Operations Specialist

Johnson & Johnson Innovative Medicine•Añasco, PR

21h•Onsite

About The Position

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 Project Leader is responsible for providing support to the Project Leader, Manufacturing Manager and Technical teams on activities related to process and quality improvement activities. Support validation activities, documents/protocols/reports, technical reports and engineering test documents or any other project related document.

Requirements

A minimum of a Associates Degree is required
A minimum of 4 years of related work experience is required.
Bilingual (Spanish & English)
Requires proven initiative, creativity, assertiveness, and leadership abilities.
Must be able to work under pressure achieving consistently high results through associate and team efforts.
Intermediate or higher-level computer skills and use of software application(s).
Excellent communication skills, mathematical abilities, and reasoning abilities.
Good Documentation Practices (GDP) and Data Integrity knowledge is a must.

Nice To Haves

Process Excellence certification or relevant experience leading process improvements including but not limited to Lean and Six Sigma Methodologies highly preferred.
Previous experience with New Products Introduction or Process Transfers preferred.
Proficient in MS office, Change Control systems, SAP, and Adobe Acrobat is highly preferred.

Responsibilities

Supports and execute validations related to new processes, equipment and products as needed in accordance with approved protocols, quality, compliance and EHS policies
Lead training activities for associates participating in new products introduction/process transfer, process development and process improvement activities.
Create documents in computer systems, submit Change Control systems documentation such as CR, CO and other applicable documentation management system requirements (ECCS or current system) in order to approve and implement new documents or changes to existing documents.
Maintain accurate, compliant documentation throughout implementation process as per QSRs.
Support quality assurance and improvement functions as required, including, but not limited to: origination, investigation and closure of NCs, hold cage management, collaboration and leading tasks for CAPA investigations.
Participate and occasionally lead lean implementation activities as required for new products, process transfers or existing products such as 5S, Kan Bans, Workflow, Metrics, Labeling and Signs, etc.
Cross training in additional operations as required.
Participate and occasionally lead process improvement efforts related to products manufacturing, standardization, and advancement.
Assist Engineers in process installations, troubleshooting and debugging.
Understand and comply with Company’s safety and environmental policies.
Proper use of all required personal protective equipment and devices to safely perform the job as necessary.
Follow written and verbal instructions and comply with deadlines.
Perform other work-related duties as assigned by supervisor/facilitator.
Follow current compliance regulations and standards.
Supports Production System by identifying, evaluating, and resolving problems.
Understands and adheres to Production System Principles and Rules.
Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)
Responsible for communicating business related issues or opportunities to next level leaders.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.