qaspecialist-i-2011-4

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  • 8/3/2019 QASpecialist-I-2011-4

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    Position : Quality Assurance Specialist I

    Reports to: Quality Assurance Manager

    Departmen t: Quality Assurance

    Date Revised: March 2011

    FLSA Status: Exempt (salary)

    Scope:

    This position helps to coordinate and conduct the activities of the Quality Assurance Department at LAHIin accordance with USDA regulations. This position also promotes and builds team concepts and effortsboth within the department and the company. This position also works very closely with Production,

    Quality Control, Process Improvement, Avian Services, and Regulatory Departments.

    Duties and Responsibilities:

    1. Responsible for maintaining LAHI documentation as related to production, testing, distribution andrecord keeping for LAHI products. This includes working with each department to ensure their

    Standard Operating Procedures (SOPs), records and other documentation are up to date and incompliance with the Approved Outline of Production.

    2. Maintain a complete and accurate filing system for all QA documents, raw materials, antigen andfinal product information to include routine purging of archived files as well as maintainingpermanent electronic files of critical data from archived information.

    3. Compiles and reviews data for submission on APHIS Form 2008s for release of product by theUSDA.

    4. Work with the QA Manager and Quality Assurance Specialist II in the investigation and disposition ofCustomer Complaints, QA Holds, Stop Sale(s), Product Recall(s) and Return Authorization

    procedures.

    5. Assists in ensuring timely and correct procedures are taken for the destruction of final product,components, and antigen in accordance with the appropriate SOP.

    6. Participates in internal and vendor audits and conveys findings to QA Manager. May lead a team ofauditors as requested by the QA Manager.

    7. Recommends specific training programs and quality workshops to enhance the process knowledgeof technicians as identified by the results of conducted procedures. Organizes and leads thetrainings/workshops as approved by QA Manager.

    8. Provides technical support for technicians ensuring compliance with 9CFR regulations.9. Promotes and builds team concepts by working in conjunction with all departments to strive for a

    common goal of improvement through support rather than highlighting mistakes.10. Other duties as assigned; including those to backup and assist QA Department members and the

    Receptionist.

    11. This position may require some travel.

    Job Description

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    Qualifications:

    Must have a minimum of an associates degree in a science related field, bachelors degree preferred. Aminimum of five years of direct experience in quality, and interpretation of USDA/FDA regulations will be

    considered in lieu of a degree. Required to have a working knowledge of SOPs and experience incompliance to governmental regulations (USDA and/or FDA). Must be proficient in both Word and Excel.Experience in team leadership, and overall quality education and assessment is required. Must possessadvanced oral and written communication skills as well as above average organizational skills andexceptional attention to detail.

    Note: All Lohmann Animal Health International job descriptions are guidelines to assist employees inawareness of qualifications and performance expectations for their respective positions. It is not possibleor desirable to commit every detailed aspect of each job to a written description. Each employee isexpected to continually improve their knowledge and understanding of their job requirements and to usethis information to increase insight as to the scope for their responsibilities. Job descriptions alone cannotbe used as an argument to refuse work assignments.

    Incumbent Signature Date