QA Process Specialist

19 set - Provincia di Latina
Johnson & Johnson

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 **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. **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. **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.#LI-Hybrid **Required Skills**:
**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**:

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