B. Braun

  • QA Associate – Quality Systems

    Job Locations US-PA-Breinigsville
    Requisition ID
    2018-13182
    Company
    Aesculap Biologics
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8 a.m. to 5 p.m.
    Site
    Aesculap Biologics
  • Overview

    Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body’s own regenerative power to improve the quality of patient’s lives.

    Responsibilities

    Position Summary:

    The QA Associate (Quality Systems) will be responsible for supporting the review and release of raw materials, in process components, and final product in support of Cell manufacturing operations to assure compliance with cGMPs and Good Tissue Practices.  The QA Associate will also be responsible for managing quality systems processes including Deviation, OOS, CAPA, and Supplier Corrective Action Requests.  This position is responsible for product safety and quality and has a direct impact on patient safety. All job functions must be carried out responsibly, competently and conscientiously to ensure that Aesculap Biologics’ products are safe and effective.

     

     

    Responsibilities: Essential Duties

    • Interprets and understands relevant laws and standards and provides guidance to Operations, Development and Quality staff to provide instruction, advice, and enforcement of GMP/GTP compliance.
    • Authors, Reviews, and approves SOPs, batch records and other documents and records (Deviation, OOS, SCAR) for accuracy, consistency and compliance with relevant federal and state regulations
    • Develops technical documents including Quality system records, SOPs, work instructions, material inspection plans, investigations, etc. in compliance to applicable laws and standards.
    • Conducts raw material, in-process and finished product release activities and provides oversight for control of non-conforming product.
    • Reviews supporting documentation and approves / releases incoming materials according to inspection specifications.
    • Facilitates the establishment of product and materials’ specifications, and process and product improvements in conjunction with Operations and Quality Assurance staff.
    • Provides oversight to ensure that environmental monitoring is performed and recorded to monitor and maintain aseptic processing conditions.
    • Manages quality systems discrepancies and facilitates the implementation of corrective and preventive action (CAPA).
    • Provides and tracks quality metrics related to discrepancies, OOS, CAPA.
    • Investigates, tracks, and resolves product complaints and Out of Specification incidents.
    • Participates in cross-functional design, development, improvement and investigative activities (root cause analysis).
    • Applies the use of Quality Tools, such as FMEA, in design, development, improvement and investigative activities.
    • Performs internal and external audits to GMP/GTP compliance, Quality Standards, and Aesculap Biologics’ policies and procedures.
    • Prepares audit plans and reports and develops corrective and preventive action and subsequent follow up activities to ensure corrections.
    • Facilitates and actively participates in third party and regulatory inspection activities (PAI).
    • Creates, prepares, and presents Quality System Management Review and GMP training. 
    • Must comply with applicable ISO and FDA regulations as stated in Quality Manual
    • Must embody the Company’s Vision, Mission and Values
    • Other quality related duties may be assigned

     

    Expertise: Knowledge & Skills

    • This position may be exposed to potentially contaminated instruments and blood or other bodily fluids.  In compliance with Occupational Safety and Health Administration (OSHA) regulations, AB will provide a safe working environment for all employees.
    • The ability to gown and mask for performance or observation of aseptic processing in a clean room environment is required.
    • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to effectively present information to top management, public groups, and/or boards of directors.   
    • Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals.  Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. 
    • Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • BS/BA in the life sciences, engineering, or related field is required.
    • 0-3 years of Quality System / GMP experience in Pharmaceutical, Biotech or Medical Device industry is desirable.
    • The ability to process, analyze and present data for the effective presentation of concepts and ideas.  Some knowledge of basic statistical analysis is required.
    • Must have ability to exercise judgement and prioritize and execute the appropriate course of action(s) as dictated by the complexity of the scenario.
    • Must be adaptable, customer service oriented, have a positive attitude.
    • Must be detail oriented and have strong organizational skills.
    • Must be able to work independently and effectively as part of a team, exhibiting effective interpersonal skills.  
    • Strong Computer skills in spreadsheet and word processing applications is required. 
    • Excellent technical oral and written communication skills are required.

     

    Desired:

    • Working knowledge and experience with process improvement and analysis tools (e.g. Pareto analysis, control charts, Root Cause analysis, FMEA, etc.) is a plus.
    • The ability to interpret the cGMPs/GTPs, federal and state regulatory requirements is a plus.
    • Experience with Document Management, Training Management, Maintenance Management and ERP systems is a plus.

     

    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 employee must occasionally lift and/or move up to 30 pounds.

    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.  This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.

    The noise level in the work environment is usually moderate.

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