Quality Assurance Associate (New Product Introduction)

Posted 7 Days Ago
Be an Early Applicant
Latina, ITA
In-Office
30K-49K Annually
Junior
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Support New Product Introduction (NPI) quality activities ensuring cGMP compliance during tech transfer and product launch. Provide QA presence on shop-floor, review project documentation, participate in cross-functional project teams, manage deviations, investigations, CAPA and change control, support inspections, and apply in-process assurance to production readiness.
Summary Generated by Built In

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.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:

Business Enablement/Support

All Job Posting Locations:

Latina, Italy

Job Description:

A proposito di Innovative Medicine

La nostra esperienza in Innovative Medicine è ispirata dai pazienti, la cui conoscenza alimenta i nostri progressi scientifici. I visionari come te lavorano in team che salvano vite sviluppando le cure del domani.

Unisciti a noi nello sviluppo di trattamenti, nella ricerca di cure e nel pionieristico percorso dal laboratorio alla vita, sostenendo i pazienti in ogni fase del percorso.

Per ulteriori informazioni, visitare il sito Web https://www.jnj.com/innovative-medicine

Stiamo cercando il miglior talento nel ruolo di Quality Assurance Associate basato a Latina.

Scopo:

Il/La Quality Assurance Associate ha l’obiettivo di garantire la conformità alle GMP, alle procedure aziendali e ai requisiti normativi durante le fasi di introduzione di nuovi prodotti, technology transfer e lancio commerciale. La risorsa supporta attivamente le attività NPI assicurando che processi, documentazione e sistemi siano robusti, conformi e pronti per la produzione clinica e/o commerciale, contribuendo al mantenimento dello stato di compliance del sito e alla qualità, sicurezza ed efficacia dei prodotti.

Per questo ruolo è previsto un contratto a tempo determinato di 12 mesi.

La persona ricercata sarà responsabile delle seguenti attività:

  • Fornire supporto Quality alle attività del reparto NPI (New Product Introduction)

  • Supportare l’introduzione di nuovi prodotti, i progetti di technology transfer e i technical launch nel sito

  • Garantire la presenza QA durante le attività di shop-floor connesse a NPI e ai transfer tecnologici

  • Collaborare come riferimento Quality nei team di progetto cross-funzionali (NPI, Technology Transfer, Validation Process, Technical Launch)

  • Revisionare tutta la documentazione di progetto rispettando le tempistiche e assicurando che i documenti siano allineati alle cGMP e in compliance

  • Partecipare in modo attivo alle riunioni sia con reparti di sito che con figure globali, portando la voce della qualità.

  • Evidenziare prontamente i rischi associati ai progetti che si sta seguendo ed evidenziarli prontamente al proprio responsabile.

  • Supportare il proprio responsabile nella preparazione delle ispezioni legate all'introduzione dei nuovi prodotti.

  • Applicare il concetto di In Process Assurance a supporto delle attività produttive

  • Gestire eventi e deviazioni in accordo alle GMP, conducendo indagini, valutazioni di impatto e definendo azioni correttive e preventive (CAPA)

  • Supportare la definizione, implementazione e chiusura dei CAPA, monitorandone l’efficacia

Qualifiche / Requisiti:

  • Laurea magistrale o diploma in discipline scientifiche, o combinazione equivalente di istruzione ed esperienza in ambito farmaceutico

  • 1–3 anni di esperienza nel settore Quality Assurance, preferibilmente in contesti NPI o in ambienti regolati

  • Conoscenza delle GMP e dei processi di introduzione di nuovi prodotti

  • Esperienza nella gestione di documentazione di produzione, deviazioni, CAPA e Change Control

  • Familiarità con sistemi informatici di qualità (es. SAP)

  • Ottime capacità analitiche, attenzione al dettaglio e problem solving

  • Buone capacità comunicative e predisposizione al lavoro in team cross-funzionali

  • Proattività, autonomia e orientamento al miglioramento continuo

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here’s what you can expect:

  • Application review: We’ll carefully review your CV to see how your skills and experience align with the role.

  • Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

  • Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

  • Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

                                                                                                                                         

Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

#LI-Hybrid



Required Skills:



Preferred Skills:

Accountability, Administrative Support, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing

  


The anticipated base pay range for this position is:

€29,800.00 - €48,530.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.


*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.



Skills Required

  • Master's degree or diploma in scientific disciplines (or equivalent education/experience)
  • 1-3 years of experience in Quality Assurance
  • Experience in New Product Introduction (NPI) or regulated environments
  • Knowledge of GMP and new product introduction processes
  • Experience managing production documentation, deviations, CAPA and Change Control
  • Familiarity with quality IT systems (e.g., SAP)
  • Strong analytical skills, attention to detail, and problem-solving
  • Good communication skills and ability to work in cross-functional teams
  • Proactivity, autonomy and continuous improvement orientation

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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