Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst 1, Stability QC!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.
Proud to be an equal opportunity employer!
The Associate Analyst QC conducts analytical testing of stability samples submitted to the QC laboratories according to testing schedules in a productive and efficient manner.
- 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 aligned with applicable environmental, health, and safety regulations
- Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing
- Sample and reference standard management. Update QC documents using the Document Management System
- Maintain individual training completion in a compliant state
- Complete corrective and preventative actions (CAPA), as assigned
- Support the investigation and resolution of laboratory nonconformances
- Provide input to functional laboratory meetings and take actions as a QC representative at cross-functional meetings
- Perform independent troubleshooting and has basic root cause analysis skills. Works directly with supervision for resolution of sophisticated issues
- Occasionally assist the supervisor in prioritizing within the functional QC laboratory
- Supports the development and execution of CREDO action plans and initiatives
Education and Experience
- A minimum of a Bachelor's degree is required, preferably in Science or related field
- Related experience is required
Knowledge, Skills, and Abilities:
- Detailed knowledge of analytical technologies used in the QC laboratory
- Skilled in performing basic and some advanced testing within the functional laboratory
- Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory
- Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
- Basic technical writing skills
- Ability to manage an individual project with mentorship from supervision/management
- Ability to execute equipment and software qualification protocols
- 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 supervision
- Knowledge of process excellence tools and methodologies
- Creativity in regard to basic problem solving and troubleshooting in laboratory tasks
- Capability to develop improvement ideas and work within a team to implement associated solutions.
- Ability to positively influence peers
- Positive and optimistic with the ability to act as a pro-active change agent
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]