QC Lead Analyst

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 Lead Analyst to be in Gurabo, PR.

The QC Lead Analyst ensure the conformance of current Good Manufacturing Practices, current JJIM Policies, all pharmacopeias (USP, Ph.Eur, JP and CHP) Standards and Procedures requirements in all activities conducted under Quality Control (QC) Laboratories.

The QC Lead Analyst is responsible for establishment and implementation of standard processes to support quality targets are achieved.

These include the implementation and/or surveillance on harmonized practices among laboratory areas, assuring compliance with different pharmacopoeia and regulations.

Support the process excellence activities in the QC laboratory including the execution of projects that increase process efficiencies, reduce cycle time, and improve overall quality execution.

Support of the laboratory scheduling/planning process to address planning exceptions requests.

Owner for the implementation of pharmacopeia changes and training requirements.

Maintains of current Standard Operation Procedure (SOP), Work Instruction (WI), creation of new procedures contributing to the continuous improvement principles.

Supports internal/external Audit process and initiatives to improve current process and ensure compliance with Regulatory Agencies.

The incumbent candidate should be able to work and/or lead teams, communicate properly and influence others.

You will be responsible for:


* Keep the alignment JJIM Gurabo internal procedure with current JJIM QC Global


* Standards and all pharmacopeias (USP, Ph.Eur, JP and CHP) Standards and Procedures requirements and any other applicable documentation.


* Lead the creation of changes associated to current QC procedures in order to optimize QC Gurabo harmonization efforts.


* Assess laboratory performance proc...