B. Braun

  • QC Laboratory Associate I

    Job Locations US-PA-Allentown
    Requisition ID
    2018-12404
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8am to 5pm
    Site
    Allentown, PA
  • 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 Laboratory Associate I is responsible for fulfilling the needs of the Quality Control Department’s requirements for analytical testing in the biological and chemical areas, examination of product, components and performing equipment and process validations. The QC Laboratory Associate I is responsible for performing independent tasks of moderate complexity with some guidance from the higher-level positions, demonstrate some problem solving skills. The position is also responsible for the laboratory daily organizational duties.

    Responsibilities: Essential Duties

    • Perform ALL laboratory testing related to product release in accordance with FDA and ISO guidelines. The tasks cover Microbiology, LAL, Cytotoxicity and the Chemistry Departments for this generic title. Impact: Ensure that product is safe and effective.
    • Perform all activities required for the execution of the laboratory test methods in all pertinent areas. Impact: Ensure adherence to the GLP’s regulations.
    • Perform sterility testing for the Microbiology Lab. If assigned to that area. Impact: Ensure adherence to USP and FDA guidelines for sterility testing.
    • Perform Cytotoxicity testing for the Cytotoxicity Lab. If assigned to that area. Impact: Ensure adherence to USP and ISO guidelines for determining toxicity of raw and finished materials.
    • Perform bacterial endotoxins test for LAL Lab. If assigned to that area. Impact: Ensure adherence to USP and FDA guidelines.
    • Perform chemistry testing for the Chemistry Lab. If assigned to that area. Impact: Ensure adherence to ISO and FDA guidelines.
    • Maintain laboratory equipment cleaning and servicing. Impact: Ensure adherence to QSR, ISO, department and company policies.
    • Maintain laboratory inventory of supplies. Impact: Ensure adherence to departmental policies.
    • Assist in validation of laboratory test method (PQ) to support GLP and QSR requirements. Impact: Ensure compliance to FDA regulations.
    • Assist in validation of laboratory equipment (IQ/OQ/and PQ) to support GLP and QSR requirements. Impact: Ensure compliance to FDA regulations.
    • Perform GLP and general laboratory functions. Impact: Ensure adherence to departmental policies.
    • Computer literate or trainable including custom analytical instrument programs. Impact: Ensure adherence to departmental policies.
    • Write laboratory methods. Impact: Ensure adherence to departmental policies.
    • Adhere to all safety and laboratory rules. Impact: Ensure adherence to OSHA, departmental and company policies.
    • Train others in comparable tasks. Impact: Ensure adherence to departmental policies.

    Expertise: Knowledge & Skills

    • Quality Standards
    • Microbiology/Chemistry
    • Theories and Lab Practices
    • Data Compilation Techniques
    • Company/Departmental Policies
    • Computer Knowledge
    • Problem Resolution Techniques
    • Teaching Techniques
    • Computer
    • Electronic Measuring Devices
    • Calculator
    • Scientific Instrument
    • Writing
    • Oral Presentation
    • People Skill
    • Mechanical Aptitude
    • Organizational Skills
    • Meet Deadlines
    • Communicate Effectively
    • Exercise Initiative
    • Work Independently
    • Demonstrate Professionalism
    • Superior Listening Skills
    • Draw Conclusions Based on Facts
    • Interpret Scientific Data

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

    Required:

    • Associate’s degree from a two year college or high school diploma or general education degree (GED) with a minimum of one year related experience and/or training or equivalent combination of education and experience as a Laboratory Associate or comparable. Must have some knowledge of QA/QC, FDA, ISO, OSHA, GLP, cGmp.
    • 1 year QA/QC/QSR/ISO/FDA Training
    • 1 year Safety Training
    • Desired:
    • 1 year experience in the biological or chemical sciences
    • 1 year QSR/ISO experience
    • 1-2 years QC experience
    • 1 year Technical Writing experience
    • 1-2 years Computer experience
    • 1 years Mechanical aptitude

    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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