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Senior QA Associate


This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 .
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 Assurance
Job Category:
Professional
All Job Posting Locations:
Geel, Antwerp, Belgium
Job Description:
Senior QA Associate - QA-Lab
Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Senior QA Associate - QA Lab (M/F/X) as member of our Quality team overseeing the Quality Control laboratories Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates based in Geel, Belgium.
J&J Innovative Medicine Supply Chain Geel serves as Center of Excellence for the development and manufacturing of SM-API's and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. At J&J Innovative Medicine Supply Chain Quality (IMSCQ) we support the Geel site in its mission as Launch & Grow site and we are responsible for the quality oversight and final release of SM-API's and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.
As Senior QA Associate - QA Lab, you have quality oversight of the Quality Control laboratories, responsible for testing of final API, API intermediates, Raw Materials, Packaging Materials as well as Drug Product Intermediates and Cleaning Validation. In this role you report to the Senior QA Manager.
Job Description:
In this role you will be responsible for:
Establishing and maintaining strong working relationships with your partners in Quality Control (QC) laboratories as well as commercial and clinical Supply Chain
Acting as QA Point of Contact for the QC laboratories ensuring compliance with global regulations and J&J quality requirements
Supporting the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation
Supporting process improvements in the QC laboratories
Handling of lab related deviations by:
Supporting experts in finding root causes
Reviewing and approving of lab investigations and deviations
Defining, following up and concluding corrective and preventive actions
Evaluating trends in issue investigations and defining appropriate actions
Analytical method transfers: providing support and oversight during analytical method introductions
Ensuring that quality records such as investigations, CAPA's, Change Controls, analytical method transfer protocols and reports related to the QC area are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met
Provide QA oversight for projects in the QC laboratories
With focus on Quality processes, develop and foster an environment of innovative thinking through e.g. benchmark and training. Continuously challenge the status quo by finding opportunities for continuous improvement
Acting as spokesperson during Health Authority inspections and customer audits
Ensuring that deviations and complaints with potential impact on patient safety and/or product supply are properly escalated
Job Qualifications:
Master Scientific degree with a technical specialization in analytics/chemistry/biotechnology (or equivalent through experience)
Min. 6 years of relevant business experience in Chemical and/or Pharmaceutical Quality Control and/or Quality Assurance, with at least 4 years of experience in an analytical area
In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures
Strong analytical thinking skills and able to work in a flexible way under time pressure in local and global teams. Ability to make risk based decisions. Understands the business implications regarding quality positions and decisions
Strong end-to-end process thinker with a solution-oriented mindset
Strong sense of responsibility with the ability to lead and coordinate. Experience as a people leader is an asset
Demonstrates resilience and agility to drive and adapt to change
Ability to handle multiple tasks and collaborate effectively
Familiar with the concepts and tools related to Analytical Troubleshooting and can apply these in a result-oriented manner
We are looking for someone who works accurately and proactively seeks solutions and who has the necessary communication skills
You are a seasoned individual contributor, who works independently with minimal supervision
You speak and write Dutch and English fluently
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .
Required Skills:
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

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