QC Incoming Inspector

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.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for QC Incoming Inspector.

Purpose: The Quality Incoming Inspector is responsible for the sampling, inspection, and approval of packaging components, as well as the testing of both packaging components and some raw materials. Ensure compliance with all quality control policies, procedures, and systems to facilitate the timely release of high-quality products that support the supply chain process. It is essential to perform functions effectively to avoid potential consequences such as product recalls, production delays, and backorder status.

You will be responsible for:

• Performs sampling, inspection, testing, and approval of packaging components in accordance with internal and external regulations and policies, ensuring compliance with supply chain approval cycle time goals.
• Performs sampling and testing of raw materials in accordance with internal and external regulations and policies, ensuring compliance with supply chain cycle time goals.
• Inspects labeling, quantity, and materials or products to be shipped.
• Maintains the Retention Room in an organized manner.
• Audits the Certificate of Analysis and Certificate of Compliance Receiving Report for raw materials and packaging components, in accordance with internal and external regulations and policies, to meet supply chain cycle time goals.
• Maintains accurate and orderly records of all work performed and collaborates with the Technical Development group during product validation activities and the transfer of new products.
• Assigns appropriate disposition to materials/products through the Computer System within established cycle time and schedules.
• Verifies (Peer Reviewer) data/results generated by another Incoming Inspector.
• Maintains and controls documents in safe files, ensuring the protection of active records.
• If the associate acts as an Environmental Trainer Auditor, the following responsibilities apply:
• Acts as an OMP ISO 14001 Team Member, supporting the Environmental Management System Coordinator in the implementation, training, and continuous improvement of the EMS in their operational area and any other activities where required.
• Conducts monthly environmental audits in their operational area.
• Provides environmental talks on a bi-monthly basis to their operational area.
• Conducts weekly inspections of chemical cabinets in their operational area.
• Provides assistance in conducting semi-annual Environmental Management System audits at the JSC-Gurabo site.

Qualifications / Requirements:

• Bachelor’s Degree in Natural Science, preferably with a major in Biology or Chemistry, and 0–2 years of experience in a pharmaceutical GMP environment is required; or
• Associate’s Degree in Natural Science and 2–4 years of experience in a pharmaceutical GMP environment is required; or
• High School Diploma and a minimum of 4 years of experience in a pharmaceutical GMP environment is required.
• Knowledge of cGMPs and safety regulations is required.
• Fluent in both Spanish and English is required.
• Basic computer, software knowledge, and word processing is required.
• Knowledge use ANSI Inspectors Rule is required.
• Knowledge of Product & Body function is preferred.
• Availability to work 1st, 2nd, 3rd, and 12-hour shifts, including overtime, 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 (ra-employeehealthsup@its.jnj.com) or 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.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy