Deviations Specialist

Summary Arcadis is seeking a Deviations Specialist for a client in Boston, MA. Responsibilities Lead, write and review deviations and investigations for the client, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary. Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs. Strong knowledge of cGMP requirements for manufacturing. Experience working in electronic Quality Management System. Demonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenance/calibration, engineering, and validation. Deliver On‑Time Closure of Deviations to support Batch‑On‑Time‑Delivery commitments for Tech Transfer – New Product Introduction, Clinical, and Commercial Products. Other duties as assigned. Skills and Qualifications Bachelors or Advanced degree in a scientific discipline. Experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or 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. Benefits 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. Equal Opportunity Employer 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. #J-18808-Ljbffr Arcadis