Teva Pharmaceuticals USA, Inc.

Quality Control Analyst II

US-OH-Cincinnati
Requisition #
17-18860
Experience (Years)
2
Category
Quality - Quality Control

Overview

 

Actively participate as a team member supporting the technical transfer of drug products and raw materials into the QC Laboratory. Analyst will perform analytical bench chemistry according to established compendia and vendor specifications. The ideal candidate will have strong problem solving and analytical capabilities and must be able to work independently to achieve team goals and milestones.

Responsibilities

 

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.

Qualifications

EDUCATION & EXPERIENCE

 

BS or higher in science related discipline
Minimum 2 years of experience in a pharmaceutical environment

 

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