Temp - Chemist
Norwich Pharmaceuticals - Norwich, NY

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The Quality Control Chemist II / Microbiologist II supports laboratory operations including but not limited to:
  • Raw Material/Component Release Testing
  • Raw Material/Intermediate/Finished Product Release/Stability Testing
  • Cleaning Verification/Validation Testing
  • Process Validation Testing
  • Environmental Monitoring
  • Marketed Product and Clinical Stability Program
  • Purified and Potable Water System Testing
  • Compendial Method Verification/Analytical Method Development and Validation
  • Equipment/Instrument Calibration and Preventive Maintenance (Metrology)

Organization Structure:

The Quality Control Chemist II / Microbiologist II reports into the Manager Quality Control

Responsibilities:

  • Safety
  • Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. – OSHA) requirements
  • Participate in weekly/monthly safety training, identify potential safety hazards and cooperate with investigations of safety related incidents


  • Compliance
  • Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendial standards, FDA expectations and internal procedures
  • Assist with laboratory investigations to ensure they are conducted in a timely manner and are completed within established target completion dates
  • Schedule and/or performs necessary validation, qualification and calibration of laboratory equipment/instruments
  • Ensure they have been appropriately trained before performing a GMP task
  • Productivity
  • Perform assigned tasks and completes them by the established deadlines
  • Witness analytical notebooks of peers
  • Conduct testing consistent with established methods/procedures to ensure adherence to “Right-the-First Time’ philosophy
  • Perform required daily maintenance and/or calibration of laboratory equipment/instruments consistent with established SOPs/QATs
  • Perform assigned tasks related to laboratory inventory management (e.g. – reagents, columns, solvents, etc.)
  • Train other QC staff on SAP QM, lab techniques and instrumentation/equipment using SOPs, QATs, HOCs and other approved documents
  • Author various GMP documents including but not limited to: SOPs, QATs, HOCs, change controls, safe practices, protocols and reports

  • Qualifications:

  • BS in Chemistry, Biochemistry, Biology or Microbiology or related discipline; MS preferred.
  • 2-5 years experience in a pharmaceutical QC laboratory environment
  • Understanding of cGMP requirements strongly desired
  • GMP Decision Making Authority : The Quality Control Chemist II / Microbiologist II is responsible for decisions related to:

  • When laboratory management must be notified to determine whether an investigation is warranted
  • Whether they have been trained to perform a GMP task
  • Suitability of analytical equipment/instruments for use
  • When a Change Control is warranted
  • When a QC staff member has satisfied training requirements for a given task
  • When a change control is warranted

  • Norwich Pharma Services - 18 months ago - save job - block
    About this company
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    With a focus on improving patient outcomes, Norwich is a reliable partner for all stages of the product lifecycle. Norwich is a...