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QC Specialist

Company: Aerotek
Location: Verona
Posted on: April 10, 2021

Job Description:

Description:The primary purpose of the QC Specialist is to perform review of all raw analytical data in laboratory notebooks, forms, worksheets, and logbooks. This review is to ensure that the various compounds and components were tested correctly according to compendial monographs, internal analytical methods, internal specifications, client procedures, and miscellaneous research procedures as required in internal SOPs. In addition, the QC Specialist may also assist in review of protocols, summary reports, SOPs, internal analytical methods and internal specifications to ensure the document is accurate and complete. The QC Specialist will also help create CoA's, track QC audit observations and make sure corrective actions are completed and any other miscellaneous tasks as assigned.ESSENTIAL JOB FUNCTIONS:

  • Reviews laboratory notebooks, forms, and logbooks.
  • Performs review of any internal methods, specifications and protocols to ensure compliance or accuracy.
  • Assists with drafting protocols, summary reports and new or existing internal procedures or specifications.
  • Create/Amend Certificate of Analysis
  • Assists with administrative support activities such as maintaining files and processing paperwork.
  • Coordinates/assists in change and process improvements needed.
  • Coordinates and tracks client and regulatory audit observations to ensure timely closure.
  • Maintains a cGMP laboratory notebook and forms.
  • Follows all company cGMP practices, policies, and procedures.
  • Follows all company safety practices, policies, and procedures.Skills:
    • GMP
    • Chemistry
    • Quality
    • Assurance
    • Control
    • QA/QCAdditional Skills & Qualifications:Must Haves:
      • Bachelor's degree in chemistry, biochemistry, biology or related life science field required.
      • 2+ years of experience in a cGMP pharmaceutical environment.
      • Must be detail orientedExperience Level:Entry Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Madison , QC Specialist, Other , Verona, Wisconsin

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