Quality Control Analyst III

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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We are searching for the best talent for a Quality Control Analyst III to be based in Titusville NJ.

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 internal pre-identified candidate for consideration has been identified. However all applications will be considered.

Purpose: Conducts analytical testing of stability samples according to testing schedules in a productive and efficient manner.

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:

• Bachelors degree and/or equivalent degree required; preferably in Science or related field.
• A minimum four (4) 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 advanced testing within the functional laboratory using HPLC and/or UPLC.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory.
• Knowledge of process excellence tools and methodologies.
• 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.
• Demonstrate a high level of efficiency and proficiency in performing analytical testing in compliance with all regulations.
• Demonstrate a high level of understanding of analytical test methods with ability to independently execute and troubleshoot methods where required.
• Experience with Karl Fischer analysis preferred.
• Experience with Dissolution apparatus and UV preferred.
• Experience authoring Standard Operating Procedures preferred.
• Utilize electronic systems (LIMS MES LES Empower etc.) for execution and documentation of testing preferred.

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 () or contact AskGS to be directed to your accommodation resource.

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