FDA Compliance Specialist

FDA Compliance Specialist
Airgas USA, LLC - North Division, Cleveland, OH

Airgas is the nation's largest distributor of industrial, medical and specialty gases, welding supplies and related safety products. It is also the largest manufacturer of nitrous oxide in the U.S., and a leading supplier of dry ice. With nearly 1,100 locations and approximately 14,000 employees nationwide Airgas is uniquely positioned to serve our diversified customer base.

This position will be based out of our corporate office in Cleveland, Ohio and will report directly to the Director, FDA Compliance.

We currently have an outstanding opportunity for an experienced FDA Compliance Specialist at our division headquarters in Cleveland, Ohio. Reporting to the director, FDA compliance this role is focused on ensuring Division compliance with Food, Drug and Device (FDA) regulations as it relates to the production, packaging and distribution of medical gases. Also ensures company facilities are using good manufacturing practices (cGMP) related to the manufacturing, processing, packaging and/or holding of drugs and devices for finished pharmaceuticals.

The Opportunity:

- Provides FDA expertise to plant personnel for ensuring compliance with all applicable Federal and State requirements regulating the manufacturing and distribution of drug, device and food products.
- Develops materials and trains members of the local Quality Control Unit (QCU) in areas of Current Good Manufacturing Practices (CGMPs) w
- Works with other company subject matter experts in the areas of Quality and FDA compliance to develop, implement, and sustain integrated best practices.
- Performs physical audits of facilities monthly and annually to ensure conformance to Airgas Medical Drug, Device and Food Gas Standard Operating Procedures (SOP's).
- Represents, consults with and assists plant management with on-site regulatory (FDA & other agencies) and/or customer inspections and audits of the company manufacturing facilities and processes.
- Conducts follow-up reviews to ensure the completion of required corrective actions and continued plant compliance to SOPs.
- Assists in providing compliance audit and annual product review feedback to appropriate management.
- Monitors performance metrics of facility compliance to both the company's SOP's and food gas manual, and FDA regulations to identify areas of for improvement and makes recommended suggestions.
- Works in partnership with all operating companies and service related departments to develop, implement and sustain quality FDA compliance strategies, polices, guidelines, processes and best practices.
- Drafts corrective action responses associated with state, federal and customer audit observations, and reviews these with Division Director of FDA Compliance before release.
- Creates deviation requests and submits these to Division Director of FDA Compliance for review.
- Oversees the investigation of serious medical complaints.
- Ensures any procedural revisions are communicated to the manufacturing facilities and training is conducted.
- Additional duties and projects as may be assigned.

Requirements:

- Bachelor's degree in Safety, Industrial Hygiene, Business or related field. In lieu of Bachelor's Degree, must posess a High school diploma or equivalent and 5+ years of experience in the administration of compliance with FDA regulations.
- To be successful, the FDA Compliance Specialist must have a strong customer service orientation with the technical background and experience related to FDA compliance, cGMP, Board of Pharmancy , knowledge and understanding of state and local regulatory requirements, and depth of experience auditing, quality and continuous improvement
- Travel up to 50-60% with overnight stays away from home
- Experience in a multi-state distribution/retail organization desired.
- The candidate must demonstrate the influencing and leadership skills required to work and navigate within a matrixed organization and enable continuous improvement of processes to maximize the Regional Company's performance.
- Displays excellent verbal and written communication skills and excellent organizational and time management skills.
- Must hold valid driver's license and insurance including no at-fault accidents in past 3 years.
- Intermediate knowledge of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
- Ability to work under pressure to meet deadlines and execute administrative needs in a consistent and timely manner.
- Shows the ability to manage multiple priorities and juggle between Divisional and local management and demands.
- Able to read, speak, write, spell and understand English (fluent)

Benefits include competitive salary, medical/dental/prescription plans, vacation, holiday, employee stock purchase plan and 401(k) with Company match.

To express interest send your resume in MS Word format via e-mail to careersHR@airgas.com with 'FDA Compliance' in the subject line. No phone calls or third parties please.

Airgas Great Lakes
careersHR@airgas.com
www.airgas.com

Airgas is an equal opportunity employer EOE/M/F/V/D.