Quality Control Analyst I

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:

Titusville, New Jersey, 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 Quality Control Analyst I to be in Titusville, New Jersey.

The Quality Control Analyst I conducts analytical testing of stability samples according to testing schedules in a productive and efficient manner.

Key Responsibilities

• 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 moderate level of understanding of analytical test methods with ability to implement and troubleshoot methods where required, with occasional guidance from a senior Analyst / QC Supervisor.
• Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing.
• Complete analytical method qualification, validation, and transfer with mentorship.
• 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

Education

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

Required

Experience and Skills:

• A minimum one (1) year of experience in a GMP-regulated, science-related field.
• Basic knowledge of analytical technologies used in the QC laboratory.
• Skilled in performing basic and some intermediate 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 make 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.
  
  

Preferred

• Some experience with Karl Fischer analysis.
• Some experience with Dissolution apparatus and UV.
  
  

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource

The anticipated base pay range for this position is :

$59,000 to $95,000 annually

Additional Description For Pay Transparency

• This position will be located in Titusville, NJ and may require up to 10% domestic or international travel. 100% on site.
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits: ○ Vacation – up to 120 hours per calendar year ○ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year ○ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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. This job posting is anticipated to close on 04/24/2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.