QA Visual Inspection SME

Johnson & Johnson Innovative Medicine•Gurabo, PR

2d•Onsite

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. We are searching for the best talent for QA Visual Inspection SME to be located at Gurabo, PR. The QA Visual Inspection SME will serve as the site expert for visual inspection processes, ensuring compliance with global standards, site procedures, and GMP requirements at Gurabo Site. This role will oversee documentation, training, operator qualification, and technical verification activities related to visual inspection.

Requirements

A minimum of a bachelor’s degree in science with a major in Chemistry, Microbiology and/or Biology is required.
A minimum of four (4) years of experience in aseptic manufacturing, industrial microbiology, visual inspection, aseptic processing, contamination control, and/or sterility assurance is required.
Strong knowledge of GMP, Annex 1, and visual inspection regulatory requirements.
Strong analytical and problem-solving skills.
Ability to lead cross-functional teams and drive compliance.
Effective communication and training capabilities.
Must have excellent ability to write in English and Spanish.
Ability to exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.
This position requires availability of traveling, working irregular shifts, working extended hours, and might be required to work on holidays and weekends.

Nice To Haves

Advanced degree is preferred.

Responsibilities

Leads the visual inspection program for the parenteral product including ownership of the test sets, personnel training and qualification.
Ensure personnel are trained in the latest versions of visual inspection procedures.
Evaluate and approve operator qualifications for visual inspection.
Maintain control of the Operator Qualification Test Set.
Approve the Operator Qualification Test Set, including its revisions.
Ensure all quality inspection operators remain qualified and ensure visual inspection process performance is aligned to GMP regulations and procedures.
Participates in the review/approval of documents associated with visual inspection process.
Monitor defects trends and propose continuous improvement initiatives for visual inspection processes aligned to Risk Management (QSRM) process.
Maintain and ensure compliance with two separate test sets: Operator Training Test Set (for practical training) and Operator Qualification Test Set (for formal qualification).
Ensure Visual Inspection test sets are representative of routine processes and container/presentation, including accept (non‑defective) samples.
Evaluate inclusion of new identified defects from routine batches into both training and qualification test sets per NC/CAPA workflow.
Partners/participates with other functions (i.e., MSAT, Operations) to develop training related to Visual Inspection.
Design and evaluate trend evaluation and respond to adverse trends or excursions; drive RCA/CAPA and verify effectiveness.
Support internal and regulatory inspections (FDA, DEA, MCS, etc.) and corrective action processes and the implementation of quality processes.
Perform other duties as required by the team to support QA Unit activities.
Complies with the principles of conduct as expressed in our company Credo during all work-related activities.
Ensures a safe environment according to current Safety Policies and Procedures.
Inform and act immediately if any unsafe situation is detected.
Actively participates in projects, programs, safety/environmental and training, GMP’s and other activities as required and/or special activities that the Company promotes to foster employee involvement and their professional development/growth.
Ensures knowledge in current systems such as but not limited to Documentations System and Investigation System.