Job Description
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:
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 https://www.jnj.com/innovative-medicine
An 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:
- \n
- 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.
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
Qualifications/Requirements:
- \n
- Bachelor's 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.
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
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 ([email protected]) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits