Regulatory Compliance Auditor (can be located at any of our CAPS Pharmacy locations)

Central Admixture Pharmacy Services, Inc. (CAPS ) is the nation's largest network of outsourcing admixture pharmacies. CAPS, a pioneer in the outsourcing of compounded sterile preparations was founded in 1991.
State-licensed and FDA-registered, CAPS pharmacies deliver solutions from more locations than any other national compounder. CAPS provides both custom and standard solutions to hospital and outpatient providers from our 25 locations across the United States. Making over 300,000 local deliveries annually, CAPS pharmacies operate 365 days a year to dispense labeled, patient-specific and anticipatory IV prescriptions to our health system pharmacy customers.
CAPS believes safety is job one. Our goal is to provide the most comprehensive and continuous quality assurance program in the industry. We perform environmental monitoring, regular process validations, and daily process sterility testing as part of our routine Continuous Quality Assessment and Improvement Program.
The CAPS service is focused on the daily admixing, dispensing, and delivery of a variety of CSPs. CAPS uniquely trained and licensed pharmacy personnel compound a broad range of patient and non-patient specific CSPs embracing the latest compounding technology, including proprietary software for ordering prescriptions and barcode safety checks for automated and manual compounding processes.
Each CAPS pharmacy is managed by a pharmacist with well-established compounding expertise. These directors manage a team of licensed pharmacists and certified technicians trained on CAPS Standard Operating Procedures. CAPS employs a QA team of chemists, microbiologists, and on-site quality assurance personnel who are accountable independently from the admixture staff. Quality Assurance reports are provided to our clients on a quarterly basis.
Orders are sent via CAPSLink, a web-based proprietary ordering software that can manage both complex and patient-specific prescriptions like Parenteral Nutrition (PN) and anticipatory compounded (AC) non-patient-specific order requests. CAPS ordering system can also interface with your pharmacy management software for convenience and broader custom service options. Pharmacists review orders upon receipt and prepare your order using an automated compounding process and a bar coded manual-add-system (MAS) to verify ingredient accuracy.
CAPS mixes to order so you can be assured your order is freshly compounded and has maximum beyond use dating (BUD) when delivered. CAPS has a variety of delivery options including same day and next day services.
Position Summary:
This position responsible to assess, assure, and maintain State and Federal compliance for CAPS pharmacies / facilities.
Responsibilities: Essential Duties
Perform internal audits of CAPS pharmacies / facilities
Perform quality control documentations/systems
Support with planning and scheduling of internal and supplier audits
Perform external supply audits as necessary
Support Board of Pharmacy (BOP), FDA, customer, supplier, and other regulatory audits
Provide compliance support to operations
Support customer inquiries and complaint responses
Track and follow-up corrective and preventive actions (CAPAs)
Perform evaluation of the effectiveness of implemented CAPAs
Support the Supplier Quality Management initiatives
Expertise: Knowledge & Skills
Very good working knowledge of USP
Good working knowledge of other Pharmaceutical (21 CFR 210 & 211, and 503B) Quality System Regulations
Knowledge of USP, FDA, ISO and ICH requirements ISO standards
Must be proficient with Microsoft office applications
Ability to use scientific principles/process knowledge to make critical compliance decisions
Must be organized
Interact with regulatory agencies effectively
Effective verbal and written communication skills
Ability to provide training and guidance
Conflict resolution skills
Expertise: Qualifications - Experience/Training/Education/Etc
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 drivers license required
Up to 25% travel required
May require passport
CQA Preferred
Experience with State Board of Pharmacy
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.
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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services
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.

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