B. Braun

  • Mgr II GMP Training

    Job Locations US-CA-Irvine
    Requisition ID
    2018-12581
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8a - 5p
    Site
    Irvine, CA
  • 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:

     

    This position oversees CFR requirements for continuing cGMP training to keep all employees aware of their responsibilities and changing requirements for cGMP compliance.  Manage compliance to training standards, development, approval and facilitation of cGMP related training to include materials and software.  This position is responsible for continually monitoring the effectiveness of cGMP training programs and implementing modifications where necessary to maintain a state of cGMP compliance and competence to job responsibilities. Providing effective training programs will result in consistent product quality and compliance to FDA standards.

     

    Expedite the implementation of organizational initiatives by partnering with facility leadership to understand operational needs and direction, conduct needs assessments and determine training gaps. Work closely with Human Resource Information System to ensure the Learning Management System meets the needs of the business by providing reports and reporting capabilities to various levels of the organization.  

     

    Responsibilities: Essential Duties

    • Maintain and or revise cGMP training program initiatives to meet or exceed FDA requirements as well as industry standards.
    • Develop/approve cGMP related training curricula or approve external vendors that facilitate cGMP training in-house.
    • Oversee cGMP New Hire Orientation for all employees, contractors and temporary employees.
    • Ensure ongoing cGMP training is relevant to business needs and meets/exceeds regulatory expectations.
    • Monitor and track metrics related to individual and departmental training. React to the metrics to ensure compliance with training program.  
    • Provide exceptional customer service to B. Braun’s internal and external customers in all assigned tasks and foster a GMP compliance culture.
    • Conduct routine informal audits of training program elements and content to ensure continuity and compliance.
    • Prepare for and participate in internal and external audits as necessary.
    • Partner with Operations Leaders to conduct needs assessments and determine training gaps.
    • Benchmark industry and attend external training to remain current with best practices and regulatory compliance requirements.
    • Provide resources to close the training gaps within the organization.
    • Supervise and develop staff in cGMPs and personal career development
    • Develop and implement training communications.
    • Develop and implement tools to measure effectiveness of training programs
    • Travel to training related seminars, occasional travel to other sites, conventions, training and meeting attendance

    Expertise: Knowledge & Skills

    • Must have a strong understanding of Quality Systems, cGMPs and FDA regulations, Medical Device Industry Standards (US and Canadian)/Pharmaceutical Industry Standards, Internal Quality Standards, Medical Device Operations/Pharmaceutical Operations, Corporate policies
    • Knowledge of training assessment, design, development and implementation
    • Flexibility to work varying schedules to support occasional weekend, holiday and off-shift work hours.
    • Product management theory and practice
    • Knowledge of driving change
    • Knowledge of principles of strategic planning
    • Leadership – coaching, feedback, motivate, reward, provide direction and guidance to team
    • Teamwork and collaboration
    • Customer focus
    • Strong training design and facilitation
    • Presentation skills
    • Drive for results – execute
    • Relationship building
    • Strategic Planning
    • Influence- able to influence at all levels of the organization
    • Adaptability
    • Learning Management experience
    • Conduct effective meetings & facilitate to groups of all sizes
    • Effective time management – handle various responsibilities simultaneously and meet deadlines
    • Strong organizational skills, work prioritization
    • Strong written and oral communication with all levels within & outside the company
    • Effective project management – coordinate group efforts and provide leadership
    • Problem solving and conflict resolution
    • Analyze training data, metrics, budget requirements, expense projections and scheduling
    • Measure training effectiveness
    • Personal Computer – MS Office Suite

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • 3 - 5 years management experience
    • 5 years pharmaceutical manufacturing/operations and/or Quality experience to include cGMPs internal procedures and policies, FDA standards and expectations and industry standards
    • 5 years of experience with Learning Management Systems and training record management in compliance with regulatory requirements.
    • 2-3 years managing projects
    • BA/BS degree or equivalent related experience

    Desired:

    • E-learning design and development experience
    • Change Management experience
    • Knowledge and experience with Adult Learning Techniques
    • Leadership Development experience

    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. 

     

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