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  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Source: Business
  • Ad #: 11600
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Kelly Services is now hiring a Data Integrity& Scientific Systems Scientist for a contract to hire position located in Wilson, NC. This position is moving quickly, APPLY TODAY!

  • Shift: 1st Monday- Friday       
  • Relocation and Sponsorship are not offered at this time.

Summary:

Data Integrity & Scientific Systems scientist activities include instrument qualification, software validation, data integrity assurance for scientific systems and writing SOP(s). The incumbent shall manage projects and work in a laboratory setting to support the implementation of replacement analytical and microbiology related scientific systems and associated test methods. He/She shall generate validation and qualification documentation for scientific systems and assure that the system is reliable and accurate. This position will work jointly with IT personnel to establish secure retention of scientific systems data and metadata. This role will also include Microbiology & Chemistry USP Test Method Verification and In- House Test Method Validation.

This role shall assure that CGMP regulations and guidance are adhered to and allowed for flexible and risk based strategies to prevent and detect data integrity issues.

Responsibilities:

  • Accountable for implementation of multiple pharmaceutical products and excipients to ensure the successful implementation and agency approval for best in class pharmaceutical products.
  • Transition of instrumentation and associate software to Quality Control
  • Data integrity assurance for successful release testing of finished pharmaceutical products and stability support

Education:

  • BS Degree in Chemistry or closely related scientific disciple
  • 5-10 years of relevant Analytical Sciences experience in a QC pharmaceutical manufacturing setting.
  • Excellent attention to detail and working knowledge of FDA regulations/guidance
  • Experienced in GLP, GMP, USP/NF and ICH Guidelines
  • Empower 3 and multiple scientific systems is required

Skill Requirements:

  • Instrument Qualification / Software Validation
  • Technical Writing for SOP(s), Validation Documentation & Qualification Documentation.
  • Laboratory instruments and software: TOC, Particulate Analyzer, BET Analyzer, Hemostasis Analyzer, Isolator, HPLC/UPLC, UPLC-MS, Spectrophotometry, FTIR , Density Meter, Refractometer, Colorimeter, Atomic Absorption
 
Map: Wilson NC
 
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