B. Braun

  • Quality Specialist II- Microbiology

    Job Locations US-CA-Irvine
    Requisition ID
    B. Braun Medical Inc
    # of Openings
    Position Type
    Regular Full-Time
    8:00am- 5:00pm
    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.


    Position Summary:

    Provide Quality oversight over the Quality System, including but not limited to the review SOPs, protocols, reports, data (included meta data) and records generated to support the manufacturing and distribution of product.



    Responsibilities: Essential Duties

    • Conducts timely Quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
    • Assists in complying with regulatory requirements related to product safety and quality.
    • Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods and the Quality System requirements.
    • Reviews records to ensure data meets the industry requirements for data integrity.
    • Provides input and quality oversight over investigations, which includes review and approve the investigation reports.
    • Provides Quality oversight over equipment/software qualification, calibration and validation. 
    • Partners with Corporate Quality to implement centralized processes and ensures compliance to industry standards and compendial requirements.
    • May act as a "lead" or first-level supervisor and may provide leadership, coaching, and/or mentoring to a subordinate group.
    • The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. 
    • General:  It shall be the duty of every employee while at work to take reasonable care for safety and health of himself / herself and other person.



    Expertise: Knowledge & Skills

    • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, and concepts. Determines best course of action.
    • Working knowledge of quality policies and thorough understanding of FDA Regulations and ISO Standards for pharmaceutical or medical device operations.   
    • Understanding of CAPA, document control, product release, management of external audits, internal audit systems, validation, data monitoring and statistical control
    • Strong analytical, communication, critical thinking, and prioritization skills.
    • Ability to work autonomously within established guidelines, procedures and practices.
    • Advanced and specialized expertise typically developed through a combination of job-related training and considerable on-the-job experience as related to a regulated industry.
    • Ability to analyze and propose process improvements.
    • Must be able to effectively manage multiple priorities


    Expertise: Qualifications - Experience/Training/Education/Etc



    • 4-8 years of related experience (equivalent experience with Associate’s degree 6-10 years)
    • Bachelor’s degree in related field required or Associate’s Degree and equivalent experience.



    • 1 or more years supervisory experience preferred.
    • Applicable industry certification preferred.



    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.


    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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