FDA Compliance Specialist

FDA Compliance Specialist

Location:

Independence, OH
- Rockside Woods Blvd
- Management
- North BSCHorsham, PA (Regional Office) - Management, Waterford, CT (Regional Office) - Management
- Northeast Region

How will you CONTRIBUTE and GROW?

We are committed to building a diverse and inclusive workplace that embraces the unique perspectives of our employees, our customers, patients, community stakeholders, and cultures across the world. We believe that a variety of backgrounds makes our team stronger and more innovative.

At Airgas, we RESPECT, HONOR and VALUE diversity.

Airgas is Hiring for a FDA Compliance Specialist in Independence, OH!

We are looking for you!

To perform this job successfully, an individual will be supported in performing each essential duty satisfactorily. The qualifications we are looking for below are representative of the knowledge, skill, and/or ability highly valued. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Partner to guide and support the Quality Department's general FDA compliance activities including compliance auditing and regulatory assistance.

Provide specialized guidance to ensure compliance with all applicable Federal and State requirements regulating the manufacturing and distribution of drug, device and food products.

Develops and maintains strong partnerships with operations, distribution, and sales leadership in assigned region to develop, champion, implement and sustain Quality and FDA Compliance strategies, policies, standards, guidelines, processes and optimized practices. Work with global peers to develop optimized practices as it relates to the overall quality & compliance system.

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 shared understanding of the "WHY" we do what we do.

Performs 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.

Represent Airgas during on-site inspections by the FDA, other government agencies, and customers.

Maintain specialized guidance regarding current and developing food, drug, and standards and regulations and how they impact Airgas' business and quality system.

Assist in assuring and sustaining compliance with all regulatory requirements associated with medical products and processes.

Review and approve validation protocols and final reports.

Assist plants with regulatory and customer audits of manufacturing facilities.

Conducts follow-up reviews to ensure the completion of required corrective actions and continued plant compliance to SOPs.

Drafts corrective action responses associated with state, federal and customer audits observations, and reviews these with FDA Divisional Director before release.

Creates deviation requests and submits these to Division Director of FDA Compliance for review.

Coordinates the investigation of serious medical complaints.

Ensures that any procedural revisions are communicated to the manufacturing facilities and training is conducted.

Assist in providing compliance audit and Annual Product Review feedback to business entity leadership.

Assess progress toward Quality standards and champion suggestions for continuous improvement.

Additional duties and projects as may be assigned.

Required Qualifications:

High school diploma or equivalent

A minimum of 3 years of experience actively auditing locations, partnering with business leaders, championing change and representing their company during audits.

Demonstrated knowledge and experience working with Industrial and medical gases experience especially with oxygen, nitrogen and CO2 processes are required.

Knowledge of local, state and federal laws pertaining to production of drugs and medical devices is required.

Prior experience working with FDA compliance rules and regulations is required.

Demonstrated experience resolving compliance and regulatory issues in collaboration with business leadership, agencies, and public interest groups is required.

Must be proficient in Word, Excel, PowerPoint and Google Suites.

Planned and unplanned overnight travel up to 50 - 60%.

Preferred Qualifications:

College degree highly preferred.

Previous work experience in the GXP/FDA controlled environments a plus.

Experience working in a multi-state distribution/retail organization is desired.