Associate Specialist Quality Assurance

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. /ppAs 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. /ppJob Function: Quality Job Sub Function: Quality Assurance Job Category: Business Enablement/Support /ppAll Job Posting Locations: Leiden, Netherlands /ph3Job Description /h3pAbout 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. /ppLearn more at /ppThe Associate Specialist QA serves as a quality subject matter expert responsible for ensuring GMP compliance throughout the introduction and lifecycle management of products within the manufacturing environment. Working closely with Operations, Quality Control, Engineering, and Development teams, the role supports quality systems, batch release activities, documentation management, change control processes, and compliance initiatives. The Associate Specialist QA plays a critical role in maintaining product quality, supporting regulatory compliance, driving continuous improvement, and fostering a strong quality culture across the organization. /ph3Key Responsibilities /h3ulliPerform electronic batch record reviews and support batch disposition activities in accordance with GMP requirements. /liliReview and release raw materials while maintaining accurate material master data within quality systems. /liliAssess, approve, and verify change controls to ensure compliance and effective implementation of process changes. /liliReview and approve GMP documents, including master batch records, validation reviews, and shipment-related documentation. /liliPrepare release packages for Qualified Persons (QP) and support product release processes. /liliParticipate in local and global quality projects, support process optimization initiatives, and promote a culture of quality and compliance throughout the organization. /li /ulh3Requirements /h3ulliBachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline. /liliMinimum of 2 years of experience in a GMP-regulated environment within Quality Assurance, Quality Control, Manufacturing, or a related pharmaceutical/biotechnology function. /liliStrong understanding of GMP regulations, quality systems, batch release processes, change control, and compliance requirements. /liliExperience within the biotechnology or pharmaceutical industry; knowledge of gene therapy and biological products is considered an advantage. /liliExcellent analytical, problem-solving, and decision-making skills, with strong attention to detail and the ability to work independently. /liliStrong communication, influencing, and stakeholder management skills, with excellent written and verbal English; Dutch language skills are a plus. /li /ulh3Required Skills /h3ulliAccountability /liliAdministrative Support /liliCompliance Management /liliDetail-Oriented /liliDocument Management /liliExecution Focus /liliGoal Attainment /liliHuman-Centered Design /liliInternal Controls /liliProcess Oriented /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliReport Writing /li /ulh3Preferred Skills /h3ulliAccountability /liliAdministrative Support /liliCompliance Management /liliDetail-Oriented /liliDocument Management /liliExecution Focus /liliGoal Attainment /liliHuman-Centered Design /liliInternal Controls /liliProcess Oriented /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliReport Writing /li /ulh3Benefits /h3ullian 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. /lilivacation days /liliparental leave for a minimum of 12 weeks /lilibereavement leave /lilicaregiver leave /lilivolunteer leave /liliwell-being reimbursement /liliprograms for financial, physical and mental health. /liliservice anniversary and recognition awards /lilisubject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. /liliFor more information, visit Employee benefits | Supporting well-being career growth | Johnson Johnson Careers. /li /ulpThe anticipated base pay range for this position is: €38.300,00 - €61.410,00 /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 /p /p #J-18808-Ljbffr