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Quality Assurance

Company: Kelly Services
Location: Miramar
Posted on: July 15, 2019

Job Description:

Job Description

Job Summary:

Follows investigation and audit procedures, participates in investigations (Internal as well as external) and routs associated files for approvals, reviews and files applicable investigation document appropriately. Log all applicable investigations records and perform data entry in applicable reports and develop graphs of trend data.

Job Responsibilities

  • Provides support during internal or external investigation performed on site.
  • Supports the updating and managing of audit process and procedures.
  • Initiates documentation associated with Investigation and CAPA records.
  • Assign numbers to Investigation and CAPA records.
  • Routes investigations for review, approval, and archiving.
  • Track status of Investigation, CAPA, and follow-up with owners to assure timely actions and completion.
  • Communicates closure of investigation and CAPAs to organization.
  • Follow Investigation and CAPA procedures in order to monitor and trend investigation data.
  • Log and data entry of Investigation and CAPA information.
  • Develop and distribute Investigation and CAPA report on a weekly basis.
  • Develop and distribute reports and graphs as requested for trending purposes.
  • Experience developing reports and creating investigation files.
  • Works as a member of a team to achieve all outcomes;
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
  • Other duties as assigned by the manager.


    Job Requirements

    • Education

      o Associate Degree in Science, Business Administration or Healthcare Administration with 0 - 2 years of experience, or high school diploma with 3 - 4 years of experience with cGMP, CAPA, investigation process and regulated pharmaceutical/medical device industry practices.

      • Knowledge, Skills and Abilities

        o Strong knowledge of personal computer and databases such as MS Office, Word, Excel, and Power point.

        o Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility.

        o Experience managing investigation, CAPA process and writing Quality reports.

        o Demonstrated ability of having cross functional / team experience.

        o Communicates well.

        o Demonstrated Technical writing skills.

        o Ability to understand and follow operating procedures, in order to perform data entry and develop reports.

        o Must be able to effectively present information and respond to questions from management and/or peers.

        o Must be able to read, write, and speak English proficiently.

        o Ability to read, creates, and interprets charts.

        o Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

        o Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

        • Experience

          o Quality Assurance experience in the pharmaceutical or other regulated industry is required.

          Why Kelly®?At Kelly

          Services®, we work with the best. Our clients include 95 of the Fortune

          100™ companies, and more than 70,000 hiring managers rely on Kelly annually to access

          the best talent to drive their business forward. If you only make one career connection today, connect

          with Kelly.About

          Kelly Services®As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people

          around the world and have a role in connecting thousands more with work through our global network of

          talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter.

          Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

          Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

          committed to employing a diverse workforce. Equal Employment Opportunity

          is The Law.

Keywords: Kelly Services, Miami , Quality Assurance, Other , Miramar, Florida

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