Compliance Specialist - FDA
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POST DATE 3/23/2019
END DATE 11/2/2019
JOB DESCRIPTIONAre you ready to be part of a passionate and hard-working team eager to drive our business forward?
APPLY NOW AND MOVE YOUR CAREER FORWARD WITH AIRGAS AS A FDA COMPLIANCE SPECIALIST SUPPORTING THE NORTHEAST REGION!
WHAT YOU WILL DO:
The FDA Compliance Specialist focuses on ensuring the Divisions 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.
* Champions the Quality Departments 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.
WHAT YOU WILL NEED:
* Bachelors degree required. In lieu of a bachelors degree, consideration for up to 4 years of additional related experience may be accepted.
* 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 distribution/retail organization is highly desired.
* Knowledge of local, state and federal laws pertaining to production of drugs and medical devices.
* Demonstrated ability to discern and explain government (cGMP, FDA and Board of Pharmacy) regulations.
* Demonstrated knowledge of industrial and medical gases, specifically with oxygen, nitrogen and CO2 processes.
* Communicates effectively both verbally and in writing, listens effectively and clarifies 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.
* Intermediate knowledge of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook).
* Ability to work independently and under pressure to meet deadlines.
* Ability to travel throughout Rhode Island, Connecticut, Massachusetts, New York, Vermont, New Hampshire and Maine 50-60% of the time.
* Lives by Airgas safety programs, OSHA, and all related rules, regulations, procedures which are applicable to this positions responsibilities.
WE TAKE CARE OF YOU:
Airgas offers a full benefits package that includes: Medical, Dental, Vision, Life, AD&D, Short Term and Long Term Disability Insurance, Vacation, Sick, Paid Holidays, 401(k) Retirement Plan with company match, Tuition Assistance and much more!
WHO WE ARE:
Airgas, an Air Liquide company, is the 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.
Dedicated to improving the performance of its more than one million customers, Airgas safely and reliably provides products, services and expertise through its more than 18,000 associates, over 1,100 locations, robust e-Business platform, and Airgas Total Access telesales channel. As an Air Liquide company, the world leader in gases, technology and services for Industry and Health, Airgas offers customers an unrivaled global footprint and industry-leading technology and innovations.
CHECK OUT WHAT A CAREER AT AIRGAS CAN OFFER YOU!
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EOE AA M/F/Vet/Disability
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status, or disability