Quality Specialist

Quality Specialist in Wilson, NCAre you passionate about ensuring the highest standards of quality and compliance in the biopharmaceutical industry? Join Janseen Biotech, Inc., located in the vibrant city of Wilson, North Carolina, where you can make a significant impact in the field of quality assurance. Our team is dedicated to maintaining excellence in our processes and products, and we are looking for a skilled Quality Specialist to help us achieve our goals.Key Responsibilities:Ensure compliance with regulatory requirements and company policies, following current Good Manufacturing Practices (cGMP).Develop and maintain the site validation program in compliance with all regulatory and corporate requirements.Collaborate with qualification teams to review and approve commissioning and qualification documentation.Provide quality oversight for C&Q/CSV and validation execution activities.Support the development and implementation of C&Q and validation plans.Act as the QA point of contact for deviations, CAPAs, and change controls.Collaborate with cross-functional teams to address quality issues.Requirements:Bachelor's degree in a scientific or engineering discipline.2-4 years of experience in the biotherapeutic and/or pharmaceutical industry.Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides.Proficiency in technical writing for validation and quality documents.Excellent communication and interpersonal skills.Preferences:Familiarity with ISPE guidelines, including GAMP 5 and ASTM E2500.Experience with risk-based approaches to commissioning and qualification/validation.Detail-oriented mindset with a keen eye for process improvements.If you are ready to take your career to the next level and be part of a dynamic team, apply now to join us in Wilson, NC, where innovation meets quality!