Deviations Investigator

About the jobArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together.Role description:Arcadis is seeking a PFAS Analyst to support a crucial project focused on gathering and reporting data related to PFAS (Per- and Polyfluoroalkyl Substances) used across 30 of client's FDA-regulated sites. The selected candidate will play a key role in ensuring compliance with EPA requirements for pharmaceutical companies, covering the period from 2011 to 2024. This is a mid-senior level role, suited for individuals with experience in data management, procurement collaboration, and regulatory reporting.Role accountabilities:Lead, write and review deviations and investigations, including the manufacturing, facilities, supply chainmaterials management and support QC deviations as necessaryIdentify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAsStrong knowledge of cGMP requirements for manufacturingExperience working in electronic Quality Management SystemDemonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenancecalibration, engineering, and validationDeliver On-Time Closure of Deviations to support Batch-On-Time-Delivery commitments for Tech Transfer - New Product Introduction, Clinical, and Commercial ProductsOther duties as assignedQualifications & Experience:Bachelors or Advanced degree in a scientific discipline.Experience in the pharmaceuticalbiotech industry in combination with drug substancedrug product manufacture, development andor quality.Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.Experience interacting with regulatory health authorities inspections.Knowledge of global regulations and standards.Strong team player that has a customer service approach and is solution oriented.Attention to detail and the ability to work individually as well as within a multi-disciplinary team.Excellent listening, communication and interpersonal skills fostering team spirit.Consistent delivery of high-quality work at all times.Ability to gown and work in a cleanroom environment.Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.Why Arcadis?We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It's why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.You'll do meaningful work, and no matter what role, you'll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.Together, we can create a lasting legacy.Join Arcadis. Create a Legacy.Our Commitment to Equality, Diversity, Inclusion & BelongingWe want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.

Created: 2024-11-01