Job Description

QC Specialist

The successful candidate in this position is responsible for: chemical and chromatographic analyses of incoming raw material, in-process samples and final products; raw material and finished product release; stability coordination and testing; and method development, feasibility, validation, and transfer as well as drafting associated protocols and reports.

  • Essential Duties and Responsibilities:
  • Control of raw materials
  • Testing of raw material, in-process samples, finished products, and stability samples as well as completion of associated QC documentation. QC analyses include: Gas Chromatography (GC), Liquid Chromatography (LC), Mass Spectrometry (MS), Karl Fischer titration (KF), Ultraviolet-Visual Spectroscopy (UV/Vis), and miscellaneous wet chemistry lab work.
  • Review of QC analytical data as well as comprehensive analytical records.
  • Maintain, revise, and implement cGMP procedures as necessary for Quality Control (SOP’s, analytical test methods, forms, specifications, etc.)
  • Maintaining cGMP quality level of work.
  • Independently handling quality excursions such as deviations
  • Developing analytical test methods for raw materials and finished products.
  • Drafting and review of validation protocols for analytical methods as well as cleaning methods.
  • Providing analytical support in regards to customer needs/concerns.
  • Develop, optimize, and qualify/validate various analytical methods.
  • Other duties as assigned or identified
  • Required Skills, Experience, and Education:
  • BS in Chemistry or related field
  • Minimum of 2 years’ experience in a GMP environment
  • Experience with the use of analytical techniques/instruments such as GC, LC, MS, UV/Vis, KF, etc.
  • Minimum 2 years of work experience in quantitative analysis of organic compounds. New graduates with undergraduate research experience and excellent academic records will be considered.
  • Capable of or eager to learn designing method development experiments and writing protocols and reports.
  • Excellent team skills, effective organization, and presentation skills
  • Ability to work independently and effectively under minimal supervision.
  • Ability to effectively work in a fast-paced work environment.
  • Excellent problem solving and planning skills.
  • Detail oriented with the ability to troubleshoot and resolve issues.
  • Proficiency in Microsoft Word, PowerPoint, Access, and Excel.
  • Desired Skills and Experience:
  • Strong understanding of compendial/regulatory requirements (i.e. ISO 9001, USP, cGMP, ICH Q7).
  • Prior experience in the development and validation of analytical test methods, especially with respect to chromatographic test methods.

Application Instructions

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