FDA Compliance Specialist

About the Role

Focuses on ensuring the Division's compliance with Food, Drug and Device regulations which 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, 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 listed 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.

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.
• Develop and maintain 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 participate in the development of training materials and train 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.
• Perform 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.
• Conduct follow-up reviews to ensure the completion of required corrective actions and continued plant compliance to SOPs.
• Draft corrective action responses associated with state, federal and customer audits observations, and review these with FDA Divisional Director before release.
• Create deviation requests and submit these to Division Director of FDA Compliance for review.
• Coordinate the investigation of serious medical complaints.
• Ensure 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.

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.

Pay

$71,000 - $106,000 Monthly Auto Allowance

Schedule

Hybrid Schedule

Benefits

• Comprehensive Family Benefits: Airgas offers a full benefits package designed to support your whole life, including Medical, Dental, Vision, Life, AD&D, and Disability Insurance.
• Support for Parents: We offer up to 14-week paid child birth benefits to support growing families.
• Future Security: 401(k) Retirement Plan with company match, Tuition Assistance, Paid Holidays, Vacation, and Sick time.
• Early Access: Your benefits start after just 30 days of employment
• Medical, dental, and vision plans
• Short-term and long-term disability
• Life and accidental death and dismemberment (AD&D) insurance
• Employee Assistance Program (EAP)
• Pre-tax commuter transportation benefit
• Parental leave, vacation, sick time, floating holidays, jury duty and funeral/bereavement leave, and paid holidays for all eligible full-time employees
• 401k plan with company matching funds
• Tuition reimbursement
• Discounted college tuition for eligible employees' dependents
• Airgas Scholarship Program for dependent children

Associates who are members of collective bargaining units should review their bargaining agreement to determine whether they are eligible for some or all of the benefits described here and to see any special terms or conditions for eligibility.