QC Chemist I

Job Summary:

As a Quality Control Chemist, you will participate in performing routine commercial release and stability testingof pharmaceutical products and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations.


  • Perform bench work such as FTIR, HPLC, GC, dissolution, and transdermal physical testing.
  • Demonstrate flexibility/agility and follow good laboratory technique meeting QbD standards and all regulatory requirements.
  • Practice GMP documentation standards and peer review of colleague’s notebooks.
  • Demonstrate problem solving skills and be able to work independently to ensure timelines for testing are met.
  • Author required documents such as IQ/OQs, stability protocols and reports.
  • Create C of As and data summary reports for release and stability testing.
  • Take on continuous improvement projects to improve efficiency and flow within the Laboratory.

Education and Experience:

  • Bachelor’s degree in relevant science field and a minimum of 3 years’ experience in a QC or Analytical Laboratory.
  • Highly motivated and self-driven individual with ability to work independently, and multi-task, adhere to aggressive timelines in support of department and company objectives.
  • A minimum of 3 years’ experience in a pharmaceutical manufacturing laboratory environment including FDA, cGMP, USP, and other regulatory requirements for pharmaceutical industry
  • Knowledge of analytical techniques including HPLC, (GC, Karl Fisher, disintegration, and dissolution experience a plus).
  • Experience using chromatographic software (Empower 3 or Chromeleon – strongly preferred)

Preferred Skills/Abilities:

  • Highly motivated and self-driven with ability to work independently.
  • Ability to multi-task and adhere to aggressive timelines in support of department and company objectives while exhibiting a with low error rate, showing good attention to detail
  • Experience with statistical data analysis and QbD principles
  • Experience with environmental monitoring and/or aseptic technique.
  • Ability to think critically and troubleshoot analytical lab instrumentation problems (ex. HPLC)
  • Experience with analytical technical writing, communication, and data management skills to present data to internal technical and project teams & potentially to clients.

Physical Requirements:

  • Ability to work in an analytical chemistry laboratory environment following all safety protocols
  • Ability to sit at a desk and use a computer for prolonged periods of time
  • Ability to lift to 20 lbs.
  • Ability to stand at a laboratory station using equipment and instrumentation for prolonged periods of time

The above job description does not constitute a contract of employment, and LTS may exercise its employment-at-will rights at any time.

Department/Division: Quality Control Laboratory
Reporting to: Quality Control Supervisor
Grade: 10