Documentation Associate I

  • location: Deerfield, IL
  • type: Contract
  • salary: $24.10 - $28.35 per hour
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job description

Documentation Associate I

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Deerfield, Illinois
job type: Contract
salary: $24.10 - 28.35 per hour
work hours: 9 to 5
education: High School
 
responsibilities:
Handle tasks associated with the processing of post donation information, positive test results, and nonconforming reports with minimal supervision. Provide assistance in preparing, processing, and delivering quality documentation according to regulatory requirements. Maintain current and archive documentation in accordance with GMP and GDP regulations/practices.

  • Assist in the receipt and review of documentation submitted by plasma collection centers to identify plasma units determined to be unsuitable for further manufacturing (60%)

    • Review of documentation to verify accurate donor and/or plasma unit suitability assessment
    • Assist in the preparation of consignee notifications for the recall of plasma units determined to be unsuitable for further manufacturing
    • Ensure ALL Lookback assessments and Consignee notifications occur within required timeframes
  • Assist in the investigation of errors (e.g. TrackWise), including corrective and preventative actions, if applicable (10%)
  • Manage current and archive filing systems to allow quick and easy access to documentation (10%)
  • Revise and create SOPs to improve department processes (5%)
  • Assist Lookback Supervisor and/or Lead, Medical Affairs in special projects as assigned (5%)
  • Train Lookback staff in required SOPs for job functions as applicable (5%)
  • Other duties and responsibilities as assigned (5%)
 
qualifications:
  • Essential: High School diploma
  • Desired: Associate degree or equivalent or 3 years or more experience with plasma collection industry
  • Ability to work in a fast-paced, high-volume environment performing multiple tasks as part of a goal-oriented team
  • Detail-oriented with ability to detect errors in documentation
  • Ability to read and understand SOPs and GDPs
  • Excellent organizational skills
  • Ability to make decisions based on past experiences, established practices, and procedures
  • Ability to prioritize multiple projects and tasks
  • Strong written, oral, and communication skills
  • Experience creating Excel spreadsheets and PowerPoint presentations
  • Ability to evaluate processes to propose improvements
  • Excellent interpersonal and leadership skills
 
skills: SOP, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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