Product Quality Specialist

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 jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: QualityJob Sub Function: Quality AssuranceJob Category:ProfessionalAll Job Posting Locations:Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of AmericaJob Description:We are searching for the best talent for a Product Quality Specialist to be based in Raritan, NJ or Titusville, NJ.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 will be responsible for:Has end-to-end accountability for the stability management and oversight from late stage development through full commercial lifecycle for a portfolio of products.Responsible for product quality related activities with a specific expertise in stability.Supporting the work of PQI/PQO/PQL and actively contributing to overall smooth functioning of the Stability CoEBe expert in specific areas of stability managementOperate independent in the PQS role with minimal supportSupport departmental goals and activitiesPQS for Product families that are highly complex or L&G of high value requiring interactions with multiple functions and teams.Identify opportunities for improvementMentor less seasoned members of CoEParticipate in cross-functional meetings as neededSupport stability related escalations as neededSupport regulatory filings with stability information/data.Responsible for stability Protocols/reportsStability SME for assigned product, manage temp excursions, CC etc.Qualifications/Requirements:6-8 years of industry experienceEducation Bachelor’s DegreeAbility to work with others in a team environmentAbility to manage individual assignments with minimal guidanceAbility to read and interpret documents such as SOPs, work instructions, protocolsClear knowledge of stability related regsProficient with using Microsoft office applications and web-based collaborative applicationsJohnson & 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 & 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 (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource.Required Skills:Preferred Skills:Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)The anticipated base pay range for this position is :$94,000.00 - $151,800.00Additional 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Raritan, New Jersey, United States of America; Titusville, New Jersey, United States of AmericaType: Full time