B. Braun

CAPS Manager/Director QA Validation

Job Locations US
Requisition ID
2022-21023
Company
Central Admixture Pharmacy Services, Inc.
# of Openings
1
Category
Pharmacy
Position Type
Regular Full-Time
Shift
8:00 am - 5:00 pm (Monday - Friday)
Site
CAPS

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:

 

Responsible to ensure compliance with Federal and State Regulatory requirements for the validation of compounded sterile preparations (CSPs), packaging and compounding processes. Plan, organize and direct the activities related to QA Validation group to ensure timely completion of the group tasks. The QA Validation Manager is also responsible for the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to support the company goals while complying with regulatory and State requirements.

 

Responsibilities: Essential Duties

  • Manage the validation program for existing and new CSPs, compounding processes and supplies, beyond-use dating (BUD), microbiology and chemistry methods, computer systems, packaging, equipment facilities and utilities. Ensures compliance with Federal and State Regulatory requirements.
  • Provides overall direction and expertise for administration of validation/revalidation policies in compliance with Quality System Regulations and CAPS policy.
  • Implements industry standards & functions as the authority on validation strategy, procedures and techniques and regulatory compliance.
  • Provides direction and participates in validation protocol development/review and approval.
  • Conducts or directs the conduct of product performance and compounding process experiments, studies and tests.
  • Analyzes or directs the analysis trending and interpretation of experimental data and the preparation of technical reports.
  • Manages the Validation group to provide technical support and direction to the CAPS’ Operation and Quality Group. Interfaces with Regulatory agencies in conjunction with inspections, field complaint investigations and technical interchanges to represent the company position with respect to validation and quality control issues.
  • Ensures efficient use of resources in order to achieve department quality and operation plan objectives. Evaluates proposed changes to products and compounding processes to determine validation or re-validation requirements and defines qualification strategy.
  • Reviews and approves validation and test protocols for adequacy and completeness. Approves and authorizes product and CSP process changes based on review of information, test data and reports.
  • Reviews and/or recommends actions with respect to the investigation of deviations and the disposition of nonconforming product.
  • Responsible to hire, develop, promote and discipline validation personnel.

Expertise: Knowledge & Skills

  • Good working knowledge of Pharmaceutical (USP <797>, 21 CFR 210 & 211, and 503B) and Medical Device (21 CFR 820) Quality System Regulations
  • Good working knowledge of USP, FDA/cGMP, ISO, and ICH requirements
  • Expertise in Quality Control, Engineering and industrial statistics.
  • Managerial/supervisory experience. Must have excellent interpersonal and communication skills and be able to effectively work with a wide variety of disciplines and all levels of management.
  • Must have experience in effective project management and proven leadership skills.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • Requires a minimum B.S. Degree in a scientific, technical or engineering field and 8 years experience in validation of a Pharmaceutical products, systems, process, facilities, etc.
  • 5 or more years Management experience
  • Valid driver license required
  • Able to travel approximately 25% per calendar year

Desired:

  • MS or PhD in a related science

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.

 

 

 

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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:

 

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:

  • Indoors, cleanroom, and may require wearing protective cleanroom attire. The noise level in the work environment is usually moderate.

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.

What We Offer

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.

Notices

Equal Opportunity Employer Veterans/Disabled

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