Position Title: FDA Compliance Specialist Horsham, PA 50-60% travelHow will you CONTRIBUTE and GROW?The FDA Compliance Specialist focuses on ensuring the Division’s compliance with Food, Drug and Device regulations.
The Compliance Specialist provides regulatory compliance guidance by applying knowledge of FDA regulations & GRAS (Generally Recognized as Safe) requirements in addition to current Airgas Standard Operating Procedures (SOPs) related to the food, drug and device manufacturing process.In particular you will:Champions the Quality Department’s general FDA compliance activities including compliance auditing and regulatory assistance.Provides FDA expertise to ensure compliance with all applicable Federal and State requirements regulating the manufacturing and distribution of drug, device and food products.
Monitor performance against Quality standards and champion suggestions for continuous improvement.Performs investigation and 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.
Review and approve validation protocols and final reports.Represents Airgas during on-site inspections by the FDA, other government agencies, and customers.Drafts corrective action responses associated with state, federal and customer audits observations, and reviews these with FDA Divisional Director before release.Conducts follow-up reviews to ensure the completion of required corrective actions and continued plant compliance to SOPs.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 focus on the ”WHY” we do what we do.Assists in providing compliance audit and Annual Product Review feedback to business entity leadership and ensures that any procedural revisions are communicated to the manufacturing facilities and training is conducted.Additional duties and projects as may be assigned.
Are you a MATCH?To perform this position successfully, an individual must be able to perform each job duty satisfactorily.
The requirements listed below are representative of the knowledge, skills, and/or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.Bachelor’s degree in a science, business or related degree field required.
In lieu of degree, consideration for up to 4 years of additional related experience may be accepted.Required Length & Type of Experience:A minimum of 3 years of demonstrated experience resolving FDA compliance and regulatory issues in collaboration with business leadership, agencies, and public interest groups.Prior experience should include actively auditing locations, partnering with business leaders, championing change and representing organizations during compliance audits.Prior work experience in the GXP/FDA controlled environments preferred.Experience working in a multi-state manufacturing organization is highly desired.Knowledge, Skills & Abilities:Knowledge of local, state and federal laws pertaining to production of drugs and medical devices.Demonstrated knowledge of industrial and medical gases, specifically with oxygen, nitrogen and CO2 processes.Demonstrated ability to discern and explain government (cGMP, FDA and Board of Pharmacy) regulations.Communicates effectively both verbally and in writing; listens effectively andclarifies information as needed; works well with others in a team environment across the organization knowing who to engage to achieve results.
Uses candor and sensitivity in their dealings with others.Excellent organizational and time management skills to include the ability to multi-task and effectively manage projects in a diverse organization.Ability to maintain confidentiality of records.Proficient in Google suite applications and Microsoft Office (Word, Excel).Ability to work independently and under pressure to meet deadlines.About AirgasAirgas, 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.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 Health.
Air Liquide is present in 78 countries with approximately 64,500 associates globally.
Join us for a stimulating experience: you’ll find a world of learning and developmentopportunities where inventiveness is at the heart of what we do, in an open, collaborative and respectful environment.Your differences enhance our performanceAt Airgas, we are committed to building a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and culturesacross 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.