B. Braun

  • Quality Specialist I – Master Data

    Job Locations US-FL-Daytona Beach
    Requisition ID
    2018-12786
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8am to 5pm
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

     

    U.S. Facilities and Operations:

     

    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

    Responsibilities

    Position Summary:

     

    Responsible for the establishment and ongoing compliance of processes related to Manufacturing Controls, Packaging and Labeling, and Incoming Inspection Quality System Elements. Responsible for the master batch record and supporting master data within the Quality System Elements. Ensures systems and processes are properly implemented and maintained for compliant execution and documentation of batch manufacture controls, incoming material controls, and product/material traceability.   

     

    Responsibilities: Essential Duties

    • Responsible for establishing and maintaining the electronic batch record within the Manufacturing Execution System. Requires collaboration with Automation Engineering and Operations personnel to ensure compliance to all quality and regulatory requirements.
    • Responsible for QA review of MES recipes and workflows, ensuring compliance to process, quality and regulatory requirements.
    • Responsible for maintaining Quality master data for materials and inspection plans within SAP. Requires collaboration with Quality Control and Operations personnel to ensure compliance to all quality and regulatory requirements.  
    • Responsible for maintaining Quality master data within all existing data systems, as applicable, such as the Label Management System and Inventory Management System.
    • Analyzes existing systems to improve upon vertical and horizontal system interfaces and efficiencies.
    • Investigates and resolves system problems.
    • Understands quality and regulatory requirements and integrates these within the company’s Quality Management System in accordance with system capabilities. Evaluates and implements system and process improvements to ensure that quality systems continue to meet regulatory requirements and expectations.      
    • Partners with Quality Operations on quality objectives related to quality systems and processes. Serves as a centralized team member for these initiatives. Ensures that user requirements are properly defined and documented, systems are structured to meet established requirements, and training is effectively provided to all affected personnel prior to implementation.
    • Implements Corporate Operating Procedures and centralized processes and templates. Identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems are integrated.
    • Analyzes metrics and informatics to monitor the Quality System and its compliance. Identifies system and process issues, concerns or improvement opportunities and leads resolution.
    • Ensures that the Company’s Quality System policies and procedures are developed, implemented and maintained in compliance with regulatory requirements. Incorporates best practices while maintaining alignment to Company Objectives.  
    • Keeps informed of all existing and new regulatory requirements and works with Quality Operations to ensure full compliance in the Company’s Quality Systems.
    • Supports B. Braun affiliates on quality system and compliance matters, as required.
    • Serves as a key quality systems expert to functional business units and Quality Operations.
    • Travel to any B. Braun and/or vendor facility, domestic and internationally, when necessary.

    • Keep abreast of changes in the regulations, interpretation of the regulations and revising internal practices and written procedures to comply with the regulatory requirements.

    Expertise: Knowledge & Skills

    • Thorough knowledge of batch record requirements, quality policies and systems, FDA Regulations for pharmaceutical operations. Working knowledge of electronic batch record and MES systems desired.

    • Strong working knowledge of all Quality System elements, such as CAPA, Risk Management and root cause investigation, document control, validation, design controls, and process controls.

    • Must be able to work with all functional groups. Must demonstrate ability to work in a team setting to evaluate and resolve issues.

    • Ability to apply a broad knowledge of Quality Assurance principles, practices, and procedures to complex tasks.

    • Demonstrated skills in adaptability, team working, and interpersonal relationships are required in order to effectively perform this job function.
    • Strict attention to detail required. Problem detection ability a must.
    • Excellent written and verbal communication and interpersonal skills
    • Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • Bachelor’s degree required
    • 4-8 years professional experience
    • Minimum 4 years experience with FDA requirements, cGMPs, and an ability to interpret regulatory requirements
    • Experience with quality assurance standards such as ISO, ICH, USP & GxP

    Desired:

    • Advanced degree or certifications 

    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.

     

    Other

    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 employee must occasionally lift and/or move up to 30 pounds.

    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.

     

    IN-2017

    LI-JA1

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