B. Braun

QA Validation Spec III

Job Locations US-FL-Daytona Beach
Requisition ID
2017-11391
Company
B. Braun Medical Inc
# of Openings
2
Category
Quality
Position Type
Regular Full-Time
Shift
8am - 5pm
Site
Corporate/Sales/ B. Braun of Canada/ BIS/ CeGat

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:

 

The QA Validation Specialist III will work with the QA Validation team. In this position the individual will be responsible for supporting Engineering and Quality for new equipment, software or processes or modifications to existing equipment, software or processes on site. 

 

Responsibilities: Essential Duties

 

  • Work as part of the CORE team to develop and support QA Validation Develop, execute, review and approve Validation Protocols and Reports based on a competent understanding of the Validation Lifecycle;
  • Investigate and write Exception Reports in Validations;
  • Participate on cross-functional teams to implement Process Analytical Technology (PAT) and continuous improvement systems and methodologies;
  • Perform root cause analysis, investigation and management;
  • Lead or support Project team meetings, tracking and reporting;
  • Execute validations in timely and compliant manner to meet the needs of the company;
  • Mentor and train other team members;
  • Lead and implement risk management and risk based approaches
  • Work with Corporate QA to ensure validation requirements and practices are up-to-date and continuously improving;
  • Create and maintain site work instructions or procedures for execution of Validation that ensure compliance with current industry and B. Braun corporate requirements;
  • Interface with cross functional teams and ensure positive working relations;
  • Perform data analysis using statistical methods as appropriate and make educated decisions based on data;
  • Effectively use software systems needed for the Validation process (i.e. B. Docs, Temperature Mapping Equipment);
  • Create, review and approve a Change Control;
  • Maintain understanding of new and modified products;
  • Work effectively with outside vendors;
  • Support Analytical test methods and laboratory equipment validation as needed; 

Expertise: Knowledge & Skills

 

  • Use of computer programs including Word, Excel, Project, Adobe, Minitab, Visio.
  • Good communication/personal skills;
  • Ability to read and write in English;
  • Ability to read and understand procedures and regulations;
  • Ability to analyze data in a comprehensive manner;
  • Ability to present information properly in multiple forms of communication (i.e. written, verbal);
  • Ability to work with different individuals on multiple levels;
  • Ability to prioritize work load and alert management if timelines will be missed or technical issues arise;
  • Mathematic aptitude for highly complex math including statistics;
  • Knowledge of the following Regulations and Standards:
    • 21CFR Parts 11, 210, 211, and 820
    • US FDA CDER 2011
    • GHTF/SG3/N99-10-2004
    • EU Guidelines for Good Manufacturing Process for Medical Products for Human and Veterinary Use, Annex 15: Qualification and Validation
    • ICH Guidelines for Industry Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients
    • ASTM E2500
    • GAMP 5
  • Ability to travel to other sites when requested;
  • FAT/SAT experience

Qualifications

Expertise: Qualifications - Experience/Training/Education

 

Required:

  • Bachelor's degree from a four-year college or university;
  • Prior Validation experience (≥6 years) required;
  • Experience working in a regulated environment for the Biotech, Pharmaceutical, or Medical Device Industries;
  • Experience with equipment, process, and software Validations.

Preferred:

  • 5S, Root Cause Analysis, 6 Sigma Green Belt, Process Analytical Technology (PAT);
  • Risk Analysis (FMEA)
  • Statistical knowledge for sampling plan development and process data evaluation;
  • Interaction with Regulatory bodies (FDA, TUV, EU) and customer audits.

 

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 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.

LI-JA1

IN-2017

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