QA Assistant

Johnson & Johnson; Latina; In loco; EUR 34.000 - 54.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson is seeking a QA Assistant for its Borgo San Michele site in Latina to ensure products meet GMP and quality standards, and to support documentation and QC processes.

You will review procedures, support investigations, and contribute to corrective actions while working within the Quality Assurance team to prepare for inspections and ensure continuous improvement across the plant.

Competenze

• 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.

Mansioni

• Perform all controls required by procedures for second-level approval of Batch Records.
• Act as Quality Leader/Quality Approver in the management of investigations, ensuring appropriate review and approval of records.
• Ensure that investigations are complete, that compliance and quality impact are properly assessed, and that appropriate corrections and corrective actions are defined and implemented.
• Investigate complex quality issues (non-conformances) and ensure appropriate communication within and outside the site; act as Escalation Lead in accordance with the relevant procedure.
• Ensure that non-standard shipments and shipments under Quarantine are managed in compliance with procedures.
• Support the different site departments in resolving issues with potential quality impact and actively contribute to the definition of improvement actions.
• Participate in cross-functional meetings to define site business priorities and organize team activities in line with defined capacity, ensuring execution of both standard and fast-track activities.
• Contribute to the effectiveness and efficiency of the Quality System by monitoring departmental KPIs and implementing appropriate improvement actions where necessary.
• Actively participate in the department’s preparation for Regulatory and Customer inspections and act as Subject Matter Expert (SME) during inspection execution.

Conoscenze

English ( fluent )

Formazione

Master's degree in a scientific field

Strumenti

Microsoft Office

Descrizione del lavoro

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 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 Assistant 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 Assistant, you will:

• Perform all controls required by procedures for second-level approval of Batch Records.
• Act as Quality Leader/Quality Approver in the management of investigations, ensuring appropriate review and approval of records.
• Ensure that investigations are complete, that compliance and quality impact are properly assessed, and that appropriate corrections and corrective actions are defined and implemented.
• Investigate complex quality issues (non-conformances) and ensure appropriate communication within and outside the site; act as Escalation Lead in accordance with the relevant procedure.
• Ensure that non-standard shipments and shipments under Quarantine are managed in compliance with procedures.
• Support the different site departments in resolving issues with potential quality impact and actively contribute to the definition of improvement actions.
• Participate in cross-functional meetings to define site business priorities and organize team activities in line with defined capacity, ensuring execution of both standard and fast-track activities.
• Contribute to the effectiveness and efficiency of the Quality System by monitoring departmental KPIs and implementing appropriate improvement actions where necessary.
• Actively participate in the department’s preparation for Regulatory and Customer inspections and act as Subject Matter Expert (SME) during inspection execution.

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.

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.

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!