KEY DUTIES AND RESPONSIBILITES
- Perform analyses and tests of drug products, raw materials, in-process materials, release test samples or stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications
- Perform a variety of qualitative tests or qualitative assays on samples using techniques that vary from standard analytical equipment to modern and automated instrumentation.
- Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data
- May aid in maintenance and certification of test instruments and apparatus to ensure compliance
- Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation
- Will be directly involved in establishing requirements for transfer of analytical methodologies from other Teva facilities, including AR&D.
- Ability to write technical documents (i.e. protocols, reports, change controls, SOPs)
- Advanced knowledge of analytical chemistry, chromatography (HPLC/UHPLC) and drug dissolution testing.
COMPLIANCE AND QUALITY
- Thorough knowledge and understanding of USP, cGMP, ICH and FDA guidelines
- Create and maintain lab record documentation (notebooks and computer based) according to GMPs
Maintain a clean and safe work environment and follow safety procedures and policies.