Sr Operations Support Specialist – Investigations

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 https://www.jnj.com

Job Function:
Supply Chain Manufacturing

Job Sub Function:
Manufacturing Process Improvement

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.

The Specialist – Investigations is responsible to investigate, document and bring to conclusion the outcome of product/processing related incidents, deviations or documentation errors reported under the guidance of the Sr Operations Support Supervisor - Investigations and the Sr Operations Support Manager - Investigations.

Apply investigative tools and techniques to identify and evaluate the cause of an event including root cause analysis, impact or risk analysis, corrective and preventative actions and monitoring efficiency of implemented actions to follow the FDA and other Regulatory cGMPs investigation requirements/guidelines.

Recommends, proposes, and formalizes alternatives for the improvement of processes, utilities and systems.

Key Responsibilities:


* Responsible for thoroughly investigating events as it relates to deviations or documentation errors and applying a science-based approach to accurately, correctly and timely document the final report applying appropriate investigation techniques and/or tools.


* Reviews and uses the established follow-up mechanism to ensure that applicable investigations are initiated, timely completed, final reports issued and approved by QA.


* Evaluates and discusses the impact of the reported events to ensure that its effect on previously approved product has been considered as part of the investigation process and that actions are identified to prevent its recurrence.


* Reviews and evaluates each event under investigation against the applicable metrics defined/implemented to monitor the effectiveness of corrective and/or preventive actions and communicates results to site management on the established frequency or as agreed upon.


* Maintains an updated knowledge of the cGMP regulations and FDA/Other R...