Regulatory Compliance Auditor

Overview

CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.

Responsibilities

Position Summary:

This position is responsible for conducting audits of quality and regulatory compliance of compounded sterile drug products at client pharmacies in customer settings such as hospitals, home infusion pharmacies, and other compounding pharmacies.

Responsibilities: Essential Duties

• Conduct regulatory compliance and quality audits at client pharmacies and evaluate their compliance to the requirements contained in USP chapters 797 and 800.
• Present audit findings to client pharmacies by preparing written reports and power point presentations.
• Serve as a quality and regulatory compliance subject matter expert for USP 797 and USP 800 in engagements with various types of client pharmacies such as hospital pharmacies, home infusion pharmacies and specialty compounding pharmacies.
• Maintain current, comprehensive expertise in applicable quality and regulatory requirements.
• Advise clients on sterile pharmacy compounding, pharmacy cleanrooms, USP 797 requirements, USP 800 requirements, cGMPs for Outsourcing Facilities and other regulations associated with sterile pharmacy compounding.
• Relate to customers in a professional manner using excellent interpersonal skills.
• Create and manage files generated from each audit.
• Travel as necessary for site evaluations and audit work.

Expertise: Knowledge & Skills

• Excellent knowledge of USP and USP .
• Working knowledge of other Pharmaceutical (21 CFR 210 & 211, and 503B) Quality System Regulations.
• Excellent verbal and written communication skills.
• Must be proficient with Microsoft office applications.
• Must interact with customers effectively.
• Must be organized.
• Excellent verbal and written communication skills.
• Ability to provide training and guidance.

Preferred Requirements:

• Internal and Supplier Auditing Experience
• Working knowledge of FDA and State Board of Pharmacy regulations
• External Audit Support
• American Society for Quality & Certified Quality Auditor Certifications

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• BS degree in technical or scientific discipline , or equivalent experience
• 3 - 5 years experience in Pharmaceutical/medical device industry, 2 of which are in compliance or equivalent experience
• Valid driver's license required.
• Up to 50% travel required.
• May require passport.

Desired:

• Experience with a State Board of Pharmacy or FDA.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com..

Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Notices

Equal Opportunity Employer Veterans/Disabled