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Company: PPD
Location: Middleton
Posted on: June 25, 2022

Job Description:

JOB DESCRIPTIONSummarized Purpose:Conducts internal and/or external audits to ensurecompliance with established quality assuranceprocesses, standards, global regulatory guidelines and/or client contractual obligations. Identifies andaddresses non-conformance issues. Assists in the delivery of quality services for contracted qualityassurance audits, internal site audits, laboratory audits and file audits for clients and projects. Applies company policies and procedures to resolve routine issues.
Essential Functions:

  • Conducts a variety of routine client, internal or GxP audits
  • Assists or may conduct non-complex process audits
  • Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
  • Serves as a resource to operational departments on audit or quality assurance subject matter
  • Assists in the preparation of audit findings and/or other related informationPPDLABS
    #GDJob QualificationEducation and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-1 year) or equivalent combination of education, training, & experience.Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisionsKnowledge, Skills and Abilities:
    • Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
    • Thorough working knowledge of Standard Operating Procedures and Working Practice Documents
    • Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
    • Strong attention to detail
    • Able to work independently or in a team environment
    • Good problem solving abilities
    • Good organizational and time management skills
    • Basic computer skills and ability to learn and become proficient with appropriate software
    • Proven flexibility and adaptability
    • Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelWorking Conditions and Environment:
      • Work is performed in an office/ laboratory and/or a clinical environment.
      • Exposure to biological fluids with potential exposure to infectious organisms.
      • Exposure to electrical office equipment.
      • Personal protective equipment required such as protective eyewear, garments and gloves.Physical Requirements:
        • Ability to work in an upright and /or stationary position for 6-8 hours per day.
        • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
        • Frequent mobility required.
        • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
        • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
        • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
        • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
        • Frequently interacts with others to obtain or relate information to diverse groups
        • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
        • Regular and consistent attendance.Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.COVID-19 Vaccination Update for U.S. Colleagues
          • All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.
            • All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: PPD, Madison , ASSOC QA AUDITOR - ENTRY LEVEL, Accounting, Auditing , Middleton, Wisconsin

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