Quality Control 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.