QA Assistant

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

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Career growth programs

Insurance plans

Descrizione del lavoro

Johnson & Johnson Innovative Medicine in Latina, Italy is seeking a QA Assistant for Borgo San Michele. The role enforces GMP, reviews batch records, and supports QA investigations to ensure compliant documentation and product quality.

You will work with the Quality Assurance team to align with internal standards and regulatory expectations, contributing to site improvements and cross-functional collaboration.

Competenze

• Master’s degree or diploma in a scientific field, or equivalent experience.
• Minimum 2 years in quality in pharma and experience as an investigator.
• Excellent English language skills and proficiency with MS Office.

Mansioni

• Perform controls for second-level approval of Batch Records.
• Act as Quality Leader/Quality Approver for investigations.
• Ensure investigations are complete with proper corrections and actions.
• Investigate complex quality issues and communicate with site stakeholders.
• Manage shipments under Quarantine per procedures.
• Support site departments to resolve issues with potential quality impact.
• Participate in cross-functional meetings to set priorities and plan activities.
• Monitor Quality System KPIs and drive improvement actions.
• Prepare for Regulatory and Customer inspections as SME.

Formazione

Master’s degree or diploma in a scientific field

Descrizione del lavoro

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 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.

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:

• 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.
• 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
• 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.