Quality Assurance Auditor
Company: Airgas Inc
Posted on: November 9, 2019
Are 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 QUALITY
ASSURANCE AUDITOR, SUPPORTING THE NORTHEAST REGION!
WHAT YOU WILL DO:
The Quality Assurance Auditor focuses on ensuring the Divisions
compliance with Food, Drug and Device regulations. The Quality
Assurance Auditor 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
* Champions the Quality Departments general FDA compliance
activities including compliance auditing and regulatory
* 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
* 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
* 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 is
* 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
* 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
* Ability to travel throughout Rhode Island, Connecticut,
Massachusetts, New York, Vermont, New Hampshire and Maine 50-60% of
* Lives by Airgas safety programs, OSHA, and all related rules,
regulations, procedures which are applicable to this positions
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
CHECK OUT WHAT A CAREER AT AIRGAS CAN OFFER YOU!
What do our Team Members have to say about being part of the
Great place to work with great growth potential - Director,
Opportunity to advance and a great safety program - Driver,
Fun people to work with and flexible management - Sales
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,
Keywords: Airgas Inc, Albany , Quality Assurance Auditor, Accounting, Auditing , Albany, New York
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