QC Analyst (Analytical Instrument and Lab Systems)

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:
Wilson, North Carolina, United States of America

Job Description:

We are currently seeking a highly qualified individual to join our team as a QC Analyst (Analytical Instrument and Lab Systems) at our new Large Molecule Drug Substance Manufacturing facility in Wilson North Carolina (BioNC).

In this key role, you will be responsible for laboratory equipment lifecycle management and CSV support, among others. 

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

Essential Job Duties and Responsibilities:


* Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.


* Author SOP’s, Work Instructions and protocols.


* Responsible for the quality control laboratory equipment lifecycle management and CSV support.


* Participate in activities to introduce technologies and computer base applications to a new site, for example eLIMS/iLABS, SDMS, Empower and SoftMax Pro, to improve laboratory efficiency and promote a culture of Innovation.


* Interact with the QC Global organization for the different center of excellence for equipment and information technologies.


* The resolution of unexpected complex compliance or lab instrument and system issues as they arise

Qualifications:


* Bachelor’s Degree in Chemistry, Biochemistry, Micro or science related field with 4+ years related experience in biopharmaceutical or pharmaceutical industry.

And/or an equivalent combination of education and experience.


* Working knowledge of regulatory requirements, policies and guidelines.

Experience with Quality Control document reviews and regulatory inspection processes.


* Working knowledge of laboratory systems.


* Strong technical knowledge in and experience with QC analytical equipment is required.


* Knowledge of cGMP regulations and FDA/EU guidance is required.

Other Requireme...