Quality Technician I

J&J Family of Companies; Añasco (PR); On-site; USD 36,000 - 48,000; Full time

Job summary

Johnson & Johnson in Anasco, Puerto Rico, seeks a Quality Technician I to audit batch records for completeness and correctness, maintain lot history, and generate NCRs, certificates, and reports as needed.

This role requires a high school diploma (associate degree preferred) and 2 years in a medical devices or pharmaceutical quality environment, with proficiency in Excel and Word and willingness to work overtime across shifts.

Qualifications

• High School diploma required; Associate’s Degree preferred.
• 2 years of experience in Medical Devices or Pharmaceuticals environment required.
• Experience in Quality and documentation preferred.
• Proficiency in Microsoft Excel and Word required.
• Availability to work overtime and various shifts, including weekends/holidays.

Responsibilities

• Audits all Batch Records for completeness and correctness across Processing, Packaging and Inspections.
• Manage Batch Records Retention process.
• Use computer systems for Inventory Transactions.
• Recommend redesigns of batch records for ease of use.
• Generate Quality, Compliance, and Analysis certificates as applicable.
• Perform activities related to product release or hold.
• Support ISO 14001 initiatives and environmental objectives.
• Train new personnel on Batch Record auditing (OJT).
• Adhere to Environmental, Safety and Industrial Hygiene policies.

Skills

Quality control

Batch records auditing

Documentation

Excel

Word

Overtime availability

Attention to detail

Education

High School diploma

Associate's Degree preferred

Tools

Microsoft Excel

Microsoft Word

Job description

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 (https://www.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:

Anasco, Puerto Rico, United States of America

Job Description:

About MedTech

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

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 Quality Technician I.

Purpose: Responsible for auditing all batch records for completeness and correctness and filing of records. Maintains lot history records, fills logbook data, and generates NCRs, certificates, and reports if required. Adheres to environmental policy, procedures, and supports department environmental objectives.

You will be responsible for :

• Audits all Batch Records to ensure completeness and correctness including: a) Reviews for completeness and correctness of Processing, Packaging and Inspections on Batch Records. b) Assures non-conformance closure and that releases are authorized. c) Ensures any required corrective actions in the batch record are completed and in accordance with pre-established procedures and QSR requirements.

• Managers (maintains and purges) the Batch Records Retention Process.

• Uses computer systems for Inventory Transactions.

• Makes recommendations for the redesign or design of batch records for ease of use.

• Generates certificates (Quality, Compliance, and Analysis) as applicable.

• Performs activities related to physical and electronic product release or hold.

• Identifies and participates in continuous improvement projects and programs to achieve work simplification, cost reduction and to eliminate non-value-added activities. Performs other duties as assigned.

• Assists in training new personnel on Bath Record auditing process by providing On the Job Training (OJT).

• Observes all Company Environmental, Safety and Industrial Hygiene policies and regulations.

• Provides support to ISO 14001 Team Member/ Leader of his/her department and to Environmental officer for the implementation, training, deployment and continuous improvement of the organization’s ISO 14001 system.

Qualifications / Requirements:

• A minimum of High School diploma is required. An Associate’s Degree is preferred.

• Two (2) years of experience in a Medical Devices or Pharmaceuticals environment is required,

• Experience in Quality is preferred.

• Experience in documentation preferred.

• Computer literate with knowledge in Microsoft Excel and Word programs is required.

• Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

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 and 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 email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

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. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

LI-Onsite

Required Skills:

Preferred Skills:

Agility Jumps, Compliance Management, Curious Mindset, Customer Centricity, Detail-Oriented, Document Management, Factory Acceptance Test (FAT), Persistence and Tenacity, Process Oriented, Professional Ethics, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Regulatory Compliance, Technical Support