Sr Regulatory Compliance Auditor

Central Admixture Pharmacy Services, Inc.


Sr Regulatory Compliance Auditor

US--

Job ID: 2023-23279
Type: Regular Full-Time
# of Openings: 1
Category: Regulatory
All CAPS locations

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:

Responsibilities: Essential Duties

• Performs internal audits of CAPS pharmacies / facilities.
• Performs quality control documentations/systems.
• Supports with planning and scheduling of internal and supplier audits.
• Performs external supply audits as necessary.
• Supports Board of Pharmacy (BOP), FDA, customer, supplier, and other regulatory audits.
• Provides compliance support to operations.
• Supports customer inquiries and complaint responses.
• Tracks and follow-ups on corrective and preventive actions (CAPAs).
• Performs evaluation of the effectiveness of implemented CAPAs.
• Supports the Supplier Quality Management initiatives.

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry.
• Influences the development of and drives the application of principles, theories, concepts.
• Determines best course of action.
• Work under minimal supervision.
• Relies on experience and judgement to plan and accomplish assigned goals.
• May periodically assist in orienting, training, and/or reviewing the work of peers.
• Judgement is required in resolving complex problems based on experience.
• Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations.
• May consult with senior management.

Target Based Range

$71,640 - $89,560

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required or equivalent combination of education and experience.
• 04-06 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, Valid driver's license and passport

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.

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Additional Information

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:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull, Stand
• Frequently:Sit, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Stooping/squatting, Walking
• Frequently:Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:Proximity to moving parts
• Frequently:N/A
• Constantly:N/A

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.

• Noise Intensity:Moderate
• Occasionally:Production/manufacturing environment, Warehouse environment, Lab environment
• Frequently:Office environment
• Constantly:N/A

What We Offer

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Notices

Equal Opportunity Employer Veterans/Disabled

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Compensation details: 89560

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About the Company:
Central Admixture Pharmacy Services, Inc.