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 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, and standards and regulations and how they impact Airgas' business and quality system. Assist in assuring and sustaining compliance with all regulatory requirements associated with medical products and processes. Review and approve validation protocols and final reports. Assist plants with regulatory and customer audits of manufacturing facilities. Conducts follow-up reviews to ensure the completion of required corrective actions and continued plant compliance to SOPs. Drafts corrective action responses associated with state, federal and customer audits observations, and reviews these with FDA Divisional Director before release. Creates deviation requests and submits these to Division Director of FDA Compliance for review. Coordinates the investigation of serious medical complaints. Ensures that any procedural revisions are communicated to the manufacturing facilities and training is conducted. Assist in providing compliance audit and Annual Product Review feedback to business entity leadership. Assess progress toward Quality standards and champion suggestions for continuous improvement. Additional duties and projects as may be assigned. Are you a MATCH? Required Qualifications: High school diploma or equivalent A minimum of 3 years of experience actively auditing locations, partnering with business leaders, championing change and representing their company during audits. Demonstrated knowledge and experience working with Industrial and medical gases experience especially with oxygen, nitrogen and CO2 processes are required. Knowledge of local, state and federal laws pertaining to production of drugs and medical devices is required. Prior experience working with FDA compliance rule s and regulations is required. Demonstrated experience resolving compliance and regulatory issues in collaboration with business leadership, agencies, and public interest groups is required Must be proficient in Word, Excel, PowerPoint and Google Suites. Planned and unplanned overnight travel up to 50 - 60%. Preferred Qualifications: College degree highly preferred. Previous work experience in the GXP/FDA controlled environments a plus. Experience working in a multi-state distribution/retail organization is desired. Benefits medical dental vision plans short-term and long-term disability life and accidental death and dismemberment (AD&D) insurance Employee Assistance Program (EAP) pre-tax commuter transportation benefit parental leave vacation sick time floating holidays jury duty funeral/bereavement leave paid holidays for all eligible full-time employees 401k plan with company matching funds tuition reimbursement discounted college tuition for eligible employees' dependents Airgas Scholarship Program for dependent children Associates who are members of collective bargaining units should review their bargaining agreement to determine whether they are eligible for some or all of the benefits described here and to see any special terms or conditions for eligibility. Your DIFFERENCES enhance our PERFORMANCE At Airgas, we are committed to building a workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their race, gender, sexual orientation, religion, disability or any other protected characteristic. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world. About Airgas Airgas, an Air Liquide company, is a leading U.S. supplier of industrial, medical and specialty gases, as well as hardgoods and related products; one of the largest U.S. suppliers of safety products; and a leading U.S. supplier of ammonia products and process chemicals. Through the passion and diversity of its 18,000 associates, Airgas fosters a culture of safety, customer success, sustainability and innovation. Airgas associates are empowered to share ideas, take initiative and make decisions. Airgas is a subsidiary of Air Liquide, a world leader in gases, technologies and services for industry and healthcare. Present in 60 countries with approximately 66,500 employees, Air Liquide serves more than 4 million customers and patients. Join us for a stimulating experience: At Airgas, you matter and so does the work you do. As a member of our team, you play an important role in the success of your team, making sure our products are created sustainably and delivered safely and efficiently. In turn, you'll find a welcoming workplace where you're valued for who you are and where you can fill your potential while growing a fulfilling career - whatever path you choose. Equal Employment Opportunity Information We are an equal opportunity employer. We welcome all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. Airgas, an Air Liquide Company is a Government contractor subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974 and Section 503 of the Rehabilitation Act of 1973. Airgas does not discriminate against qualified applicants with disabilities, and is committed to providing reasonable accommodations to the known disabilities of such individuals so as to ensure equal access to benefits and privileges of employment. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact us by email at View email address on click.appcast.io. California Privacy Notice #J-18808-Ljbffr AIRGAS INC AND SUBSIDIARIES