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Job Description

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.

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

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The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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 drivers license required
• Up to 25% travel required
• May require passport

• cGMP training/experience required.

• Aseptic processing training/experience required.

Desired:

• 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.

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.

Equal Opportunity Employer Veterans/Disabled

Compensation details: 83852 Yearly Salary

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