Qa Process Specialist

Johnson; Italia; In loco; EUR 34.000 - 54.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Descrizione del lavoro

Johnson & Johnson in Latina, Italy, seeks a QA Process Specialist to join the Quality team at Borgo San Michele. You will ensure product compliance with GMP and regulatory standards, review procedures, and work with quality systems to maintain documentation and quality controls.

You will manage investigations, lead escalation, mentor new hires, and support production and quality assurance across the site, interfacing with global functions as needed.

Competenze

• Master’s degree or diploma in a scientific field or equivalent experience in pharma.
• At least 2 years of quality experience in a pharmaceutical company and as an investigator.
• Excellent English language skills; strong MS Office knowledge.

Mansioni

• Manage complex investigations ensuring GMP and regulatory compliance.
• Act as Quality Leader in investigation approvals and strategy definition.
• Lead escalation processes following company procedures.
• Coach new hires in investigation training and coordinate shop floor activities.
• Backup in Quality Oversight for Production and QC, tracking annual plan and improvements.
• Maintain presence in operations and train personnel on new regulations.
• Serve as Quality reference for LCM projects and support NPI as needed.

Conoscenze

Administrative Support

Communication

Compliance Management

Controls Compliance

Execution Focus

ISO 9001

Persistence and Tenacity

Problem Solving

Quality Control (QC)

Quality Control Testing

Quality Standards

Quality Systems Documentation

Quality Validation

Report Writing

Standard Operating Procedure (SOP)

Teamwork

Technologically Savvy

Formazione

Master’s degree or diploma in a scientific field

Strumenti

Microsoft Office

Descrizione del lavoro

QA Process Specialist

Salary : €33,700 - 54,395 yearly

Azienda : Johnson Tipo Lavoro : Full Time Italy JobCopilot will tailor your resume and auto-fill the application

Descrizione Lavoro - QA Process 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 Control

Job Category:

Business Enablement/Support

All Job Posting Locations:

Latina, Italy

Job Description:

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for QA Process Specialist to be in Borgo San Michele – Latina.

Purpose:

For our manufacturing site in Borgo San Michele (Latina), we’re looking for a permanent hire to join the Quality team. The role focuses on making sure our products fully comply with national and international pharmaceutical regulations, both in terms of quality control and documentation.

You’ll be part of the Quality Assurance team, helping ensure that processes and products meet GMP and internal quality standards. This includes reviewing procedures and working with quality systems and tools.

As a QA Process Specialist, you will:

• Manage complex investigations ensuring compliance with GMP, regulatory, and company requirements.
• Act as Quality Leader in the approval of investigations and contribute to the definition of investigation strategies.
• Act as Escalation Lead, facilitating the escalation process in accordance with company procedures.
• Serve as a tutor for new hires in investigation training, supporting them through proper planning until full autonomy is achieved; coordinate the team during support activities to operational departments on the shop floor.
• Act as backup in the Quality Oversight process for Production and Quality Control departments, contributing to strengthening the site’s compliance status: execution of controls defined in the annual plan, coordination of periodic meetings with management to evaluate results, trends, and improvement opportunities.
• Ensure a constant presence in operational areas, providing support in training personnel on new regulations and ensuring that all procedures and work instructions are aligned with the applicable quality system.
• Act as Quality point of reference for projects related to LCM products, serving as the first point of contact for the technical department and interfacing with all involved global functions.
• May act as backup in the management of NPI projects.

Qualifications / Requirements:

• Master’s degree or diploma in a scientific field, or an equivalent combination of education and experience in the pharmaceutical industry.
• At least 2 years of experience in quality field in a pharmaceutical company, and experience as an investigator.
• Excellent English language skills.
• Good knowledge of Microsoft Office suite.

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:

Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy

Preferred Skills:

Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy

The anticipated base pay range for this position is:

€33,700.00 - €54,395.00

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.