Product Quality Specialist

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.com As 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 Quality Job Sub Function Quality Assurance Job Category Professional All Job Posting Locations Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America Job Description We are searching for the best talent for a Product Quality Specialist. 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 Purpose The Product Quality Specialist, Stability CoE, has end-to-end accountability for the stability management and oversight from Late Stage Development through full commercialization lifecycle for a portfolio of products. Responsibility for product quality related activities with a specific expertise in stability including protocol and report generation. Supporting the work of PQI/PQO and actively contributing to overall smooth functioning of the Stability CoE. You Will Be Responsible For Stability POC for a set of products families (API and Drug Product) Oversight of Sample management for stability Author/oversight of stability Protocols and Reports in accordance with global SOPs including sampling strategy Support audits and filings as appropriate related to stability questions Responsible for stability Lifecycle management Supports PQI/PQO and Business Partners with stability related questions Support temperature excursions, change controls, stability notifications and escalations as applicable. Maintain stability statements for assigned products. Partner with Stability Labs as needed to ensure questions are addressed in a timely manner. Active Member of Stability CoE: Support departmental goals. Give input on topics raised in staff meetings to support continued improvement of stability processes. Qualifications/Requirements Bachelor’s degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree is required. A minimum of 6 years of relevant experience is required A minimum of 4 years’ experience in the pharmaceutical, biotechnology, or medical device industry is required (post graduate experience and/or education will count towards years of industry experience). Experience in API and drug product stability and business implications regarding stability decisions is desired. Understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management is required. Insight in pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus. Demonstrated ability to work independently and in a team environment Relationship building as part of a team is required. Strong written and oral communication skills with various levels of the organization. Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with the ability to apply GMP regulations. Must be flexible to accommodate US, EMEA and AP work schedules when vital, balancing work and personal time This position may require up to 5-10% domestic and international travel as business demands. Required Skills Preferred Skills Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards Salary $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)). Benefits 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: - Equal Opportunity Statement 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 & 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. Country-Specific Posting Information Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). Belgium, Ireland, Italy, and Netherlands - Requisition Number: R-092525 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine