Quality Control Chemist

Lewes, DE

Quality Control Chemist – Lewes, DE
SPI Pharma, the world’s leading supplier of antacid actives and a manufacturer of formulated products for the pharmaceutical, nutritional, and OTC markets, seeks a Quality Control Chemist for its Lewes, DE site. This role is part of a fast paced, innovative Quality Control team and is responsible for ensuring that the site follows all Federal, State and company mandated quality compliance programs with emphasis on proper current, Good Manufacturing Practices, (cGMP) documentation auditing and testing.  This position reports to the Quality Control Manager.

Summary of Responsibilities:
We are looking for a skilled and resourceful Quality Control Chemist to work in our Quality Control Lab performing raw material, in process, release and stability testing.  Previous experience planning and executing method validation studies is required.  Experience in wet chemistry techniques as well as in instrumental analysis, such as UPLC/HPLC, GC, FTIR, UV, ICP, AA, Karl Fisher, and particle size analysis is required. Experience in a pharmaceutical/food/chemical manufacturing environment and in a GMP/FDA regulated  facility is a strong plus.  Basic computer skills required.  The site operates 24/7 schedule and shift work is required.  Veterans are strongly encouraged to apply.

Primary Responsibilities:

  • Perform testing on in process samples, raw materials, trial products, final products and stability samples
  • Create and/or approve labels after generation and other duties as assigned by Quality Control Supervisor/Manager
  • Maintain (cGMP) compliant documentation and data storage of testing performed
  • Perform peer review of testing completed by other analyst
  • Review in-process batch record calculations in the absence of QA personnel
  • Conduct room and equipment inspections and approve release after production cleaning in the absence of QA personnel
  • Assist with laboratory investigations that occur on-shift
  • Uses Laboratory Information Management Systems (LIMS) to maintain testing results
  • Provide backup assistance to other Quality Control associates as needed
  • Assist with customer compliant investigations as needed
  • Assist Quality Control Supervisor/Manager with tasks and projects as needed
  • Identify basic technical problems and develop solutions with the help of supervision
  • Perform problem investigations with little to no supervision


  • Bachelor Degree in science required  
  • 1-3 years of relevant work experience within the pharmaceutical or chemistry industry
  • Sound judgment in interpreting regulatory, compendial, ICH, and SOP requirements

The selected individual must have excellent organizational skills with careful attention to detail, good communication skills and the ability to work closely with operators on the production floor. Qualified candidates must be able to work in a fast-paced environment and can learn/adapt quickly to new situations. Off-shift flexibility is required.

Competitive compensation package includes first day of hire benefits:  vacation, holiday and sick pay, medical, dental, vision, life and disability insurance, 401 k match and a site bonus plan.

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