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Plastikon Healthcare is looking for a QC Chemist I responsible for conducting laboratory testing to support the cGMP manufacturing operations. This position performs tests in chemistry disciplines and supports testing for the stability program. Testing includes sampling of raw materials, and HPLC assays. This position requires attention to detail, requiring a proactive individual who can assist in new assay development and product transfers.

Job Roles required of the position:

  • Chemist, Lab Tech: Performs testing and various activities in support of these job roles and works with lab team to ensure compliance to procedures. Assumes accountability for work performed. Assists in peer review of data and documents for compliance with requirements.
  • Lab Equipment Maintenance: Performs this role in support of laboratory equipment and assumes accountability for the work.
  • Validation: Executes protocols for product transfer and USP method verification/validation. Supports validation activities in manufacturing.
  • CIMP System: Provides support for continuous improvement, Kaizen events and projects.
  • NCR System: Supports the nonconformance system through reporting of nonconformances and supporting Quality in investigation activities. Provides communication based on investigation findings.

Education/Experience:

  • Minimum Requirements: BS/MS in science major or 2 years of chemistry experience in a pharmaceutical, medical device facility, or research facility/university. Experience in USP methods, ISO standard execution, cGMP and Quality Systems.

Skills/Qualifications:

  • Wet-chemistry, HPLC FTIR, UV-Vis, AA, Flame Photometry Instrumentation, method development, validation protocol writing and reporting, calibration and lab equipment maintenance. Skills in a variety of analytical instrumentation preferred.

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