QA Assistant

ppAt 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. /p pAs 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. /p h3Job Function: /h3 pQuality /p h3Job Sub Function: /h3 pQuality Control /p h3Job Category: /h3 pBusiness Enablement/Support /p h3All Job Posting Locations: /h3 pLatina, Italy /p h3Job Description: /h3 h3About Innovative Medicine /h3 pOur 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. /p pJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. /p pLearn more at /p h3We are searching for the best talent for QA Assistant to be in Borgo San Michele – Latina. /h3 h3Purpose: /h3 pFor 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. /p pYou’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. /p h3As a QA Assistant, you will: /h3 ul liPerform all controls required by procedures for second-level approval of Batch Records. /li liAct as Quality Leader/Quality Approver in the management of investigations, ensuring appropriate review and approval of records. /li liEnsure that investigations are complete, that compliance and quality impact are properly assessed, and that appropriate corrections and corrective actions are defined and implemented. /li liInvestigate complex quality issues (non-conformances) and ensure appropriate communication within and outside the site; act as Escalation Lead in accordance with the relevant procedure. /li liEnsure that non-standard shipments and shipments under Quarantine are managed in compliance with procedures. /li liSupport the different site departments in resolving issues with potential quality impact and actively contribute to the definition of improvement actions. /li liParticipate 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. /li liContribute to the effectiveness and efficiency of the Quality System by monitoring departmental KPIs and implementing appropriate improvement actions where necessary. /li liActively participate in the department’s preparation for Regulatory and Customer inspections and act as Subject Matter Expert (SME) during inspection execution. /li /ul h3Qualifications / Requirements: /h3 ul liMaster’s degree or diploma in a scientific field, or an equivalent combination of education and experience in the pharmaceutical industry. /li liAt least 2 years of experience in quality field in a pharmaceutical company, and experience as an investigator. /li liExcellent English language skills. /li liGood knowledge of Microsoft Office suite. /li /ul h3Required Skills: /h3 ul liAdministrative Support /li liCommunication /li liCompliance Management /li liControls Compliance /li liExecution Focus /li liISO 9001 /li liPersistence and Tenacity /li liProblem Solving /li liQuality Control (QC) /li liQuality Control Testing /li liQuality Standards /li liQuality Systems Documentation /li liQuality Validation /li liReport Writing /li liStandard Operating Procedure (SOP) /li liTeamwork /li liTechnologically Savvy /li /ul h3Preferred Skills: /h3 ul liAdministrative Support /li liCommunication /li liCompliance Management /li liControls Compliance /li liExecution Focus /li liISO 9001 /li liPersistence and Tenacity /li liProblem Solving /li liQuality Control (QC) /li liQuality Control Testing /li liQuality Standards /li liQuality Systems Documentation /li liQuality Validation /li liReport Writing /li liStandard Operating Procedure (SOP) /li liTeamwork /li liTechnologically Savvy /li /ul h3The anticipated base pay range for this position is: /h3 p€33,700.00 - €54,395.00 /p h3Benefits: /h3 ul liAn 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. /li liVacation days /li liParental leave for a minimum of 12 weeks /li liBereavement leave /li liCaregiver leave /li liVolunteer leave /li liWell-being reimbursement /li liPrograms for financial, physical and mental health /li liService 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. /li liFor more information, visit Employee benefits | Supporting well-being career growth | Johnson Johnson Careers. /li li*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. /li /ul /p #J-18808-Ljbffr