Senior Analytical Data Reviewer

Target PR Range: 49-59/hr
*Depending on experience

SUMMARY/JOB PURPOSE:
Responsible for the comprehensive review of documentation, analytical data, protocols and reports generated within the Analytical Chemistry department and related third party documents to verify and ensure that the laboratory records are in compliance with all established and approved procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Review laboratory documents within and related contract manufacturers (CMO) to ensure that they are accurate and complete, and that the work performed is in compliance with applicable procedures, and analytical methods. • Review data documented by CMO laboratory personnel within laboratory notebooks, worksheets, and logbooks (e.g., instrument use and maintenance logbooks). • Review audit trail to ensure that the electronic data were generated according to applicable procedures. • Responsible for the review of documentation related to the following tests for in-process and finished product samples: Appearance, Assay, Content Uniformity, Blend Uniformity, Hardness, Loss on Drying, Water Content, Related Substances/Impurities by HPLC, Residual solvent/Impurities by GC, Dissolution, and Cleaning Verification/Validation. • Responsible for the review of documentation related to raw material tests such as but not limited to the following: Identification by IR, Limit tests (Residue on Ignition, Heavy Metals), Titration, Particle Size, and Viscosity • Communicate with CMOs to resolve issues/questions identified from analytical data review • Collaborate internally as well as with CMOs to investigate OOS and deviations • May be responsible for the review of documentation related to method validation/verification elements such as Linearity, Accuracy, and Precision. • Review results transcribed to data tables, protocols, and reports. • Update/Write methods and SOPs as required. • Perform other duties as assigned with minimal instructions.

SUPERVISORY RESPONSIBILITIES: None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education: • BS/BA degree in related discipline and five plus years of related experience Experience: • A minimum of 5 years of analytical laboratory experience in the Pharmaceutical industry using and/or reviewing techniques such as HPLC, GC, UV, IR, TLC, KF required. • 2+ years of prior hands-on experience reviewing data, documents, notebooks and worksheets generated in an analytical test laboratory is preferred. • Must have strong mathematical skills; ability to understand, review and check calculations used to perform analytical testing using various instruments in a GMP lab required. • 2-5 years of experience using laboratory instrument data acquisition software (Empower, Chemstation, Chromeleon, etc.) required. Knowledge/Skills: • Requires knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and compendial references (USP/Ph. Eur., etc.) as they apply to data/document review preferred. • Must have strong mathematical skills; ability to understand and check calculations generated during analytical laboratory testing procedures required. • Experience with Microsoft Office (Word, Excel, Power Point, etc.) required. • Ability to communicate effectively with chemists by explaining deficiencies in the documentation and providing constructive feedback to minimize recurring errors required. • Demonstrated ability to take the initiative to organize and prioritize work tasks and to work independently required.

WORKING CONDITIONS:
Commercial/Alameda: • Environment: primarily working in office • Travel not required