B. Braun

Manager/Director, Quality - CAPS

Job Locations US-AZ-Phoenix
Requisition ID
2022-21369
Company
Central Admixture Pharmacy Services, Inc.
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8am - 5pm
Site
CAPS

Overview

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.

Responsibilities

Position Summary:

Plan, organize and direct the activities related to the CAPS Quality function to ensure timely completion of the group tasks. The CAPS Manager, Quality is also responsible for the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to suppose the company goals while complying with regulatory requirements.

 

Responsibilities: Essential Duties

  • Oversees the performance of functional group to assure that products and processes meet company and regulatory requirements.
  • Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
  • Provide technical assistance and direction to the other functional groups. Interface with regulatory agencies during routine audits, field complaint investigations, and technical interchanges to present the company's view point.
  • Develop, direct and implement validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
  • Supervises the implementation of internal audit program to determine any deficiencies in the Admixing / Compounding Pharmacy Operations as they relate to current regulations.
  • Directs the investigation of excursions in Admixing / Compounding Pharmacy or other related operations resulting in abnormal operation rejections. Resolves nature of the cause, impact, disposition and corrective actions.
  • Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
  • Provides supervision to CAPS Quality Control Coordinators. 

Expertise: Knowledge & Skills

  • Broad knowledge of scientific theories, instrumentation and techniques
  • Thorough knowledge of GMPs, GLPs and pharmaceutical products.
  • Familiar with the USP, FDA, Aseptic Process, and other regulatory guidelines
  • Working knowledge of all phases of company and laboratory operations

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • B.A./B.S. degree in related science or equivalent experience.
  • Eight or more years of experience in an admixing, pharmaceutical, or medical device company.
  • Previous managerial experience

 

Desired:

  • Advanced degree

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.

Additional Information

Physical Demands:

  • 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.

 

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. 
  • Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

 

Additional Requirements:

  • Frequent travel required

Notices

Equal Opportunity Employer Veterans/Disabled

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