QA Process Specialist

Location: Borgo San Michele

Job Function:  Quality
Job Sub Function:  Quality Control
Job Category:  Business Enablement/Support
All Job Posting Locations:  Latina, Italy

Job Description  QA Process Specialist – Borgo San Michele (Latina). Permanent hire on the Quality team in a manufacturing site. The role focuses on ensuring product compliance with national and international pharmaceutical regulations, quality control, and documentation.
Responsibilities   Manage complex investigations ensuring compliance with GMP, regulatory, and company requirements.
Act as Quality Leader in the approval of investigations and contribute to 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 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   Master’s degree or diploma in a scientific field, or an equivalent combination of education and experience.
At least 2 years of experience in a 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
Salary:  €33,700.00 - €54,395.00
Benefits   An annual bonus with set target (% of pay) depending on pay grade / location, based on employee and company performance.
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.
Participation in several insurance plans.
Johnson & Johnson is an equal‑opportunity employer. We respect the diversity and dignity of our employees and recognize their merit.

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