QC Senior Scientist Microbiology and Analytical 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:
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 Senior Scientist Microbiology and Analytical Investigations to be located in Gurabo, PR.

Purpose:

Responsible for performing CAPA Microbiology and Analytical investigations identified in the Quality Control (QC) area, including, but not limited to, suspect test results for Out of Trend (OOT), Out of Specifications (OOS) and Out of Limit / Level events, and supplier related investigations for microbiological, chemical, and physical testing of raw materials, drug products, intermediaries and utilities (i.e.

water, etc.) according with internal and compendia specifications.

Assures compliance to all QC policies, procedures and systems to ensure the timely release of high-quality products in support to the supply chain process.

Subject matter expert of microbiological tests and knowledge of analytical tests performed at the QC area.

Serves as back-up of the QC Lab Services supervisor in different forums pertaining to the CAPA process.

You will be responsible for:


* Leads CAPA investigations and acts as record owner.

The responsibilities as record owner include,


* Participation in multidisciplinary meetings to evaluate events that may need to be investigated and provide status of investigation records.


* Completes risk assessment following current CAPA procedures.


* Investigates and completes the record stages on a timely manner.


* Provides rationale to proceed with the usage of the product/ lot/ material.


* Performs root cause analysis using applicable tools to identify the immediate cause or root cause of the event, as applicable based on the investigation level and impact category.


* Completes the investigation record in accordance to local and global procedures and enforces the on-time closure of records.


* Acts as owner...