B. Braun

  • QC Microbiology Lead I

    Job Locations US-CA-Irvine
    Requisition ID
    2018-12123
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    6:00pm- 6:30am
    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:

     

    Coordinate execution of routine microbiology activities and special projects with the QC Technical Service Microbiology Lab Associates and cross-functional groups to ensure efficient and effective operation. Provide technical review, direction, and approval for routine microbiology testing. Execute and lead microbiological validations and testing. Coordinate microbiology support for CAPAs, non-conformances, OOS, customer complaints, internal audits and deviations to ensure adherence to quality objectives and standards. Write protocols and report for microbiology validations/studies with the guidance from the QC Microbiology Supervisor. Manage laboratory supply purchasing and inventory.

    Responsibilities: Essential Duties

    • Coordinate executive of microbiology testing for production, R&D projects, capital projects and sustaining projects
    • Coordinate Microbiology Associates’ scheduling
    • Write protocols and reports for microbiology validations/studies with the guidance from Supervisor
    • May review current procedures and make recommendations for necessary or desirable changes.
    • Review, disposition, and provide technical direction for routine microbiology testing
    • Coordinate microbiology support for CAPA, OOS, Deviations, Internal Audit, CALNs, and product complaint investigations
    • Manage laboratory supply purchasing and inventory
    • Perform microbiological testing (Microbial identification, gram stain, microscopy, bioburden testing, growth promotion, sterility testing, and D-value evaluation).
    • Responsible for the general cleanliness and appearance of the QC Microbiology Lab by keeping laboratory equipment, supplies, and overall environment in good operation status.
    • Provide training to the Microbiology Associates.
    • Follows cGMPs, GLP, SOPs, USP, and FDA guidelines in all appropriate functions and notifies Supervisor of any observed discrepancies in the laboratory or projects.
    • Validate and/or approve test results in LIMS.
    • Prepare and maintain microbial stock on a routine basis.
    • Record data in controlled data sheets, controlled notebooks, validated spreadsheets, and/or LIMS.
    • Maintains neat and legible records.

    Expertise: Knowledge & Skills

    • Knowledge in CFR, USP, cGMP, GLP, and other FDA regulations
    • Knowledge and experience in microbiology and sterilization validations
    • Knowledge in project management
    • Ability to use Microsoft Office (Word, Access, PowerPoint, Excel)
    • Excellent verbal and written communication skills
    • Excellent organizational skills with the ability to adapt to changes
    • Knowledge of LIMS

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • BS degree in Microbiology or related field and 5 or more years of experience or an equivalent combination of education and experience.

    Desired:

    • Previous leadership 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:

    • Other duties as assigned.

    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.

    IN2017 

    #LI-EC1 

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