B. Braun

  • QC Micro Assoc IV, Sterility Testing Analyst

    Job Locations US-CA-Irvine
    Requisition ID
    2018-11879
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    7:30am - 4:30pm
    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:

    The QC Microbiology Associate IV, Sterility Testing Analyst will perform routine and advanced functions and analysis related to sterility testing (dependent upon experience) as required by the specific laboratory requirement in compliance with B. Braun and cGMP specifications.

    Responsibilities: Essential Duties

    • Collect and organizes data for Microbiology identification trend
    • Responsible for routine environmental monitoring, finished product, stability, and utilities sampling and testing.
    • Must interpret and apply specifications and operating procedures when carrying out monitoring and testing responsibilities.
    • Responsible for initial review verification of environmental monitoring, raw materials, and finished product data sheets.
    • Responsible for the general cleanliness and appearance of respective lab by keeping laboratory equipment, supplies, and overall environment in good operational status.
    • May prepare media reagents, testing materials, and equipment as required
    • Responsible for ordering and maintaining materials, supplies, office inventory and data sheets a required.
    • Records data in controlled notebooks, controlled data sheets, validated spreadsheets, and completes analysis report forms.
    • May be required to work on special projects such as investigations, and non-routine testing.
    • Maintains neat and legible records.
    • Promptly and accurately inputs data into Sapphire LIMS
    • Follows cGMPs, GLPs, SOPs, USP, and FDA guidelines in all appropriate functions and notifies Supervisor, Exempt, or Lead of any observed discrepancies in laboratory or plant operations.
    • Evaluate and trend environmental monitoring data
    • Review compiled batch records

    Expertise: Knowledge & Skills

    • Become proficient in environmental monitoring techniques specific to Microbiology.
    • Become proficient in finished product and raw material testing as required, i.e. Sterility, LAL, Bioburden and Electronic PM.
    • Learn to write and edit environmental monitoring and laboratory procedures dependant upon experience.
    • Become proficient in Microbial techniques such as Gram staining, dilutions, filtering, and evaluation of plates and test tubes for microbial growth.
    • Initiate and/or conduct the investigation for non-conformance of routine testing specifications dependant upon experience.
    • Understanding of aseptic laboratory and manufacturing processes
    • 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
    • 4 – 5 years lab experience in Pharmaceutical or Medical Device Industry

    Desired:

    • Working knowledge and/or experience in Aseptic Processing Manufacturing
    • Working knowledge and/or experience in Aseptic Processing Validation (Media Fills)
    • Working knowledge and/or experience with Isolator Technology

    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

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