HPLC Data/Chromatogram Reviewer

QA Data/Notebook Auditor

Baltimore MD 21227

Monday-Friday 8am-5pm

6 Month Contract

 

Job Summary: Perform audit of data, lab notebooks and spreadsheets related to testing. Applicants must have experience with HPLC

Key Tasks and Responsibilities:

  • Review written protocols and test methods to ensure compliance
  • Assist Project Managers to enhance compliance
  • Inform Project Managers of any deviations
  • Review all investigational reports (IR, DR, and OOS/OOT reports) to ensure proper documentation and written details
  • Train Analysts on cGMP
  • Validate spreadsheets
  • Assist Project Managers to revise/improve existing and new SOPs
  • Audit instrument logbooks every month
  • Organize and maintain protocol binders in document storage
  • Knowledge of regulatory requirements within the pharmaceutical industry
  • Develop personal goals for Management by Objectives (MBOs) with the help of supervisor, work toward those goals throughout the year.
  • Assist writing SOPs and reports as directed
  • Proficiency with Microsoft Office Word and Excel
  • Follow cGMP guidelines
  • Other duties as assigned by supervisor

 

Skills and Attributes:

  • Ability to complete projects within budget and in a timely manner
  • Ability to work independently take initiative and handle multiple tasks simultaneously with minimal supervision and adhere to reporting deadline schedules
  • Thorough understanding of cGMPs
  • Follow safety rules and regulations
  • Strong organizational skills
  • Ability to meet deadlines
  • Strong communication skills
  • Strict attention to detail
  • Superior speaking skills
  • Ability to travel

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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