Chemist I, 3Rd Shift

Planet Pharma Woodstock , IL 60098

Posted 2 months ago

SUMMARY:

  • The position is responsible for testing Cleaning, Raw Material Water, In-Process and Finished Product samples. Supports laboratory investigations, system testing and process validation and business development activities.
Specific Duties, Activities, and Responsibilities:
  • Completely, accurately and precisely prepares all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements

  • Demonstrates high ethical standards

  • Maintain current training status on relevant equipment and procedures Comply with all cGMP, regulatory, corporate and EHS requirements

  • Demonstrates ability to multi-task and prioritize work

  • Maintain laboratory in audit readiness per cGDP and cGMP practices

  • Perform peer review for testing and calculations, as necessary

  • Recognizes Out of Specification, atypical and/or anomalous data, escalates to management, as necessary

Laboratory Skills

  • Perform analytical testing and calculations on in-process bulk material, finished product, cleaning and customer samples span

  • Receive and prepare reagents and standards

  • Air dryer testing

  • Perform Calibration Checks (Balance/pH/Conductivity/Pipettes etc.)

  • Perform Rinse Water testing: TOC, Conductivity Perform Raw Material Water testing: Nitrates Operate analytical instrumentation HPLC, UV/Vis, Balances, Densitometer, Autotitrator, pH meter, Conductivity Meter, Total Organic Carbon Analyzer (TOC), Osmometer, Viscometer, Karl Fischer, Particle Counter, Malvern, Polarimeter, Microscope.. (trained on NLT 11 laboratory instruments)

  • Perform pH adjustments

  • Perform Viscosity Ostwald viscosity

  • Perform Batch release testing

  • Perform First Acceptable testing Cromolyn Sodium, Tobramycin cleaning, Budesonide, Levofloxacin, GNE and Identifications HPLC: NLT 3 HPLC assays i.e. Arformoterol Tartrate, Levalbuterol, other.

  • Autotitrator: All products and titrant standardizations

  • Wet Chemistry testing of in-process bulk material, finished product, TLC, Deliverable Volume, Opalescence, Degree of Coloration Prepare and generate reports to support Critical System Release

  • Other duties as assigned

  • Maintain analytical trending and metric tracking

  • Trains other analysts in routine testing, as necessary

  • Supports laboratory investigations and/or studies, as necessary'

  • Proficient in one of the three: Deviation or OOS/OOTr or Change Control

  • Must be able to initiate and complete LIR

  • Global TrackWise workflow for Deviations or Laboratory Investigations or Change Control

REQUIREMENTS:

  • Education or Equivalent:Bachelor of Science in Chemistry or Sciences or equivalent work experience

  • Experience: Experience in a lab setting (academic, intern or other)

Knowledge/Skills Requirements

  • Demonstrated intermediate mathematical ability.

  • High level of attention to detail, well organized and multi-task oriented.

  • Excellent documentation skills.

  • Strong communication skills both written and oral.

  • Strong problem solving and analytical skills.

  • Works well in a team environment with a variety of individuals and personalities within and between departments.

  • Review reports, etc. for accuracy and logic.

  • Must be able to multitask, be proactive and willing to take initiative and responsibility.

  • Should be familiar with cGMP and safe work practices.

  • Be organized.

  • Maintain good records and be able to access them rapidly.

  • Understand where information can be found.

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Chemist I, 3Rd Shift

Planet Pharma