PRINCIPAL PRODUCT RELEASE TECHNICIAN

Biopharma Asia; Chihuahua; Ibrido; MXN 469.000 - 725.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson in Juárez seeks a Principal Product Release Technician to ensure product release quality and compliance with GDP and ISO standards. You will perform routine inspections, access PLM systems for documents, and coordinate with NPD/Lifecycle Engineering.

Bilingual English/Spanish is a must. The role requires 6+ years in a regulated QA/QC environment and experience with SAP S4 HANA and EtQ. The position is on-site in Ciudad Juárez with strong teamwork and documentation focus.

Competenze

• 6+ years in a highly regulated QA/QC environment, preferably in Medical Device
• Experience in the Medical Device industry or medical field is preferred
• Demonstrated knowledge of manufacturing principles and procedures
• Bilingual: English/Spanish is a must
• Knowledge of Quality Systems for corrective action, product segregation, nonconformity material control and process improvement
• Ability to read, interpret, and follow written instructions and drawings

Mansioni

• Performs routine tests and analyses to assure that products comply with established specifications
• Completes record of inspection results, acceptance, rejection and disposition for entry into log books and audit records
• Work with NPD and Lifecycle Engineering to assure appropriate test techniques when needed
• Prioritize and schedule activities for product release and CoC approval
• Assist all levels of associates with training on documentation issues
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices
• Performs other duties assigned as needed

Conoscenze

Teamwork

Communication

Quality systems knowledge

GDP/ISO knowledge

Bilingual English/Spanish

Reading drawings

SAP S4 HANA

EtQ

Formazione

High School/Associate degree

Strumenti

SAP S4 HANA

EtQ

Descrizione del lavoro

At Johnson & J
and Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Business Enablement/Support

All Job Posting Locations

Ciudad Juarez, Chihuahua, Mexico

Job Description

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

We are searching for the best talent for PRINCIPAL PRODUCT RELEASE TECHNICIAN to be in Juarez City.

The position of Product Release Technician is responsible for quality assurance inspection activities while ensuring compliance to policies, procedures, GDP (Good Documentation Practices), and ISO (International Organization for Standardization) requirements for documentation for product release and the appropriate distribution thereof. Bilingual: English/ Spanish is a must.

You will be responsible for:

• In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Know and follow EES policies and procedures related to work activities performed in area of responsibility
• Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures. Complete required periodic re-training in areas such as Safety and Environmental.
• Follow all company safety policies and other safety precautions within work area.
• Promote safety to all associates that enter work area.
• Performs routine tests and analyses to assure that products comply with established specifications.
• Post training, for product codes can pull all necessary drawings/material specifications/finished goods specification from appropriate PLM system(s) in order to have up-to-date documents
• Completes record of inspection results, acceptance, rejection and disposition for entry into log books, batch audit records, and/or computer databases.
• Work with NPD and Lifecycle Engineering to assure the application of non-standard test techniques when normal procedures do not fulfill testing needs, as needed.
• Observes discussions with Quality, Engineering, and other relevant departments to learn about corrective actions for reoccurring problems.
• Prioritize and schedule activities (DHR review) for product release (CoC approval) for those product codes appropriately trained to.
• Assist all levels of associates with training and guidance on documentation issues
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements

• High School / Secondary Education or Equivalent and associate degree or minimum job experience
• 6+ years related experience in a highly regulated, quality-centric environment, preferably in a Quality Assurance (QA)/ Quality Control (QC) environment or equivalent
• Experience in the Medical Device industry or medical field is preferred
• Demonstrated knowledge of manufacturing principles and practices, and procedures
• SAP S4 HANA
• EtQ
• Bilingual: English/ Spanish is a must.
• Knowledge of Quality Systems for corrective action, product segregation, nonconformity material control and process improvement.
• Ability to use good verbal and written communication skills (technical and nontechnical).
• Ability to read, interpret, and follow written instructions and drawings.
• Ability to work in a team environment with little or no supervision.
• Ability to use excellent communication and interpersonal skills when interfacing with EES associates from all levels and functions of the organization.
• Extensive working knowledge of GDP/ISO regulations and requirements. Certifications preferred ASQ CQI, ASQ CQT

Preferred Skills

• Administrative Support
• Communication
• Compliance Management
• Controls Compliance
• Execution Focus
• ISO 9001
• Persistence and Tenacity
• Problem Solving
• Quality Control (QC)
• Quality Control Testing
• Quality Standards
• Quality Systems Documentation
• Quality Validation
• Report Writing
• Standard Operating Procedure (SOP)
• Teamwork
• Technologically Savvy