FDA Compliance Specialist

Airgas•Independence, OH

68d•Hybrid

About The Position

This role focuses on ensuring the Division’s compliance with Food, Drug and Device regulations. This is supported by a thorough understanding and working knowledge of the current Airgas Medical SOP’s and Food Gas Manual, and collaborates to apply these SOPs to the food, drug and device manufacturing process. Additionally, the role requires working knowledge and understanding of current good manufacturing practice in manufacturing, processing, packing and/or holding drugs and devices, current good manufacturing practice for finished pharmaceuticals, and a firm understanding of the FDA’s GRAS (generally recognized as safe) requirements for food products. 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.

Requirements

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 rule s 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% .

Nice To Haves

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.

Responsibilities

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.