FDA Compliance Specialist

R10095760 FDA Compliance Specialist (Open) Location: Independence, OH - Rockside Woods Blvd - Management - North BSCHorsham, PA (Regional Office) - Management, Waterford, CT (Regional Office) - Management - Northeast Region How will you CONTRIBUTE and GROW? We are committed to building a diverse and inclusive workplace that embraces the unique perspectives of our employees, our customers, patients, community stakeholders, and cultures across the world. We believe that a variety of backgrounds makes our team stronger and more innovative. At Airgas, we RESPECT, HONOR and VALUE diversity. Airgas is Hiring for a FDA Compliance Specialist in Independence, OH! We are looking for you! - $ 71,000- $106,00 - Monthly Auto Allowance - Hybrid Schedule - Comprehensive Family Benefits: Airgas offers a full benefits package designed to support your whole life, including Medical, Dental, Vision, Life, AD&D, and Disability Insurance. - **Support for Parents:**We offer up to 14-week paid child birth benefits to support growing families. - **Future Security:**401(k) Retirement Plan with company match, Tuition Assistance, Paid Holidays, Vacation, and Sick time. - Early Access: Your benefits start after just 30 days of employment Recruiter: Sophia Harris | [email protected] |(656) 263-5716 (Call/Text) Focuses on ensuring the Division's compliance with Food, Drug and Device regulations which is supported by a thorough understanding and working knowledge of the current Airgas Medical SOP's and Food Gas Manual, and collaborates to apply these SOPs to the food, drug and device manufacturing process. Additionally, working knowledge and understanding of current good manufacturing practice in manufacturing, processing, packing and/or holding drugs and devices, current good manufacturing practice for finished pharmaceuticals, and a firm understanding of the FDA's GRAS (generally recognized as safe) requirements for food products. To perform this job successfully, an individual will be supported in performing each essential duty satisfactorily. The qualifications we are looking for below are representative of the knowledge, skill, and/or ability highly valued. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Partner to guide and support the Quality Department's general FDA compliance activities including compliance auditing and regulatory assistance. Provide specialized guidance to ensure compliance with all applicable Federal and State requirements regulating the manufacturing and distribution of drug, device and food products. Develops and maintains strong partnerships with operations, distribution, and sales leadership in assigned region to develop, champion, implement and sustain Quality and FDA Compliance strategies, policies, standards, guidelines, processes and optimized practices. Work with global peers to develop optimized practices as it relates to the overall quality & compliance system. Actively participates in the development of training materials and trains members of the local Quality Control Unit (QCU) in areas of Current Good Manufacturing Practices (cGMPs) with the shared understanding of the "WHY" we do what we do. Performs physical audits annually, and monthly paper audits of drug, device and food manufacturing facilities with the emphasis of analyzing the process to ensure that it conforms to Airgas Medical Drug gas SOPs. Represent Airgas during on-site inspections by the FDA, other government agencies, and customers. Maintain specialized guidance regarding current and developing food, drug, a