QC Analyst II

Location: Titusville

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 Med Tech, 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

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:

Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for a QC Analyst II to be based in Titusville, NJ.

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

You will be responsible for:

* Perform analytical testing in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)

* Maintain a safe work environment align with environmental, health, and safety regulations

* Demonstrate a high level of understanding of analytical test methods with ability to independently implement and troubleshoot methods where required

* Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing

* Complete analytical method qualification, validation, and transfer with mentorship

* Instrument Calibration and/or Preventative Maintenance

* Assist the execution of internal audits

* Maintain individual training completion in a compliant state

* Complete corrective and preventative actions (CAPA) as assigned

* Support investigations and resolution of laboratory nonconformances

* Make contributions to, and occasionally lead, continuous improvement teams. Interaction and involvement with global project teams

* Provide input to functional laboratory meetings and take actions as a QC representative at cross-functional meetings

* May occasionally assist the supervisor in prioritizing for the functional QC laboratory

* Support the development and execution of CREDO action plans and initiatives

Qualifications/Requirements:

* Bachelor's degree and/or equivalent degree required; preferably in Science or related field.

* At least 2 years of experience in a GMP-regulated, science-related field.

* Detailed knowledge of analytical technologies used in the QC laboratory.

* Skilled in performing intermediate and some advanced testing within the functional laboratory, using HPLC and/or UPLC.

* Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory.

* Basic knowledge of compendial (USP, EP, JP, etc.) requirements

* Basic technical writing skills.

* Ability to manage an individual project with mentorship from supervision/management.

* Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols.

* Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

* Ability to makes GMP laboratory decisions both independently and with occasional mentorship from QC supervisor.

* Performs independent troubleshooting and has basic root cause analysis skills. Works directly with supervision for resolution of complex issues.

* Experience with Karl Fischer analysis preferred.

* Experience with Dissolution apparatus and UV preferred.

* Experience authoring Standard Operating Procedures preferred.

Johnson & Johnson is an…