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FDA Compliance Specialist

Company: Airgas Inc
Location: Appleton
Posted on: June 6, 2021

Job Description:

Are you ready to be a part of a passionate and hard-working team eager to drive our business forward?

Apply Now and move your career forward with Airgas as an FDA Compliance Specialist.

This person can be based in any of the following locations: Appleton WI, Davenport IA, or Roseville, MN and travel regionally about 60%.

What you will do:

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.

Your responsibilities:

  • 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.
  • The above job functions are illustrative of the duties and responsibilities associated with this position and are not intended to be all inclusive. Employee may perform other related duties to meet the ongoing needs of the organization.

What you will have:

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.
  • 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 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 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.
  • Proficient in Google suite applications and Microsoft Office (Word, Excel).
  • Ability to work independently and under pressure to meet deadlines.

PHYSICAL DEMANDS:

The characteristics listed below are representative of the physical demands required by an individual to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

  • Employee may be required to remain stationary for extended periods of time.
  • Employee may occasionally be required to traverse through office and/or manufacturing locations.
  • Employee will frequently be required to actively listen and exchange information.
  • Employee will be required to observe and assess information received via computer.
  • Requires use of computer, telephone and operation of a motor vehicle.

WORK ENVIRONMENT:

The characteristics listed below are representative of the work environment typically encountered by an individual while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

  • The noise level in the work environment is usually moderate and work may be performed in a standard office environment or in a production facility.
  • This position will require both planned and unplanned overnight travel up to 50 - 60%.
  • Must have reliable, appropriate transportation to conduct field work.

NOTE: The above stated duties are intended to outline those functions typically performed by individuals assigned to this classification. This description of duties is not intended to be all-inclusive or to limit the discretionary authority of supervisors to assign other tasks of similar nature or level of responsibility nor does it imply an employment agreement.

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.

What do our Team Members have to say about being part of the team?

"Great place to work with great growth potential" - Director, Atlanta

"Opportunity to advance and a great safety program" - Driver, Cheshire

"Fun people to work with and flexible management" - Sales Specialist

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

Keywords: Airgas Inc, Appleton , FDA Compliance Specialist, Other , Appleton, Wisconsin

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