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Quality Control Auditor
Ref No.: 18-02325
Location: Cincinnati, Ohio, Ohio
Job Title: Quality Control Analyst II/ Quality Control Auditor
Location: 5040 Duramed Rd, Cincinnati, Ohio 45213
 
EDUCATION & EXPERIENCE
  • BS or higher in science related discipline, chemistry is preferred
  • Minimum 3-5 years of experience in a pharmaceutical environment
  • Auditing or peer review experience is mandatory
 
TECHNICAL DUTIES AND RESPONSIBILITES
  • Ensure that equipment, solutions, and methods used in the Quality Control Laboratory meet all acceptance criteria and that lab notebooks and related documentation are accurate
  • Perform routine and non-routine audit of chemical testing documentation for commercial, validation and stability samples in accordance to written methodology
  • Familiarity of the qualitative and quantitative data that is typically generated using analytical instrumentation such as HPLC; GC, UV/Vis, KF and FTIR is a must
  • Experience utilizing electronic laboratory information systems such as LIMS and Empower to perform the electronic review of analytical data
  • Audit Analyst notebooks to ensure the following:
  • Test methods were correctly followed; Verify data against approved specifications, notifying management of any OOS and aberrant results;
  • Ensure that the equipment used during an analysis was within the calibration date
  • Verify the integrity and expiration date of solutions used to prepare samples
 
COMPLIANCE AND QUALITY
  • Basic knowledge and understanding of USP, cGMP, and FDA regulations
  • Review lab record documentation (notebooks and computer based) according to GMPs
  • Demonstrate the philosophy of Right First Time
  • Maintain a clean and safe work environment and follow safety procedures and policies.