System One
Overview
Senior Analytical Document Reviewer – Alameda, CA. Contract, Onsite. 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 laboratory records are in compliance with established and approved procedures.
Responsibilities
Review laboratory documents within the lab and related contract manufacturers (CMO) to ensure they are accurate and complete, and that the work performed complies 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 trails to ensure that the electronic data were generated according to applicable procedures.
Review documentation related to 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.
Review documentation related to raw material tests such as 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.
Qualifications
BS/BA degree in related discipline and five plus years of related 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.
2+ years of prior hands-on experience reviewing data, documents, notebooks and worksheets generated in an analytical test laboratory (preferred).
Strong mathematical skills; ability to understand, review and check calculations used to perform analytical testing using various instruments in a GMP lab.
2-5 years of experience using laboratory instrument data acquisition software (Empower, Chemstation, Chromeleon, etc.).
Knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and compendial references (USP/Ph. Eur., etc.) as they apply to data/document review (preferred).
Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.).
Ability to communicate effectively with chemists by explaining deficiencies in the documentation and providing constructive feedback to minimize recurring errors.
Demonstrated ability to organize and prioritize work tasks and to work independently.
Employer Information System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One provides eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #568-Clinical
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Responsibilities
Review laboratory documents within the lab and related contract manufacturers (CMO) to ensure they are accurate and complete, and that the work performed complies 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 trails to ensure that the electronic data were generated according to applicable procedures.
Review documentation related to 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.
Review documentation related to raw material tests such as 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.
Qualifications
BS/BA degree in related discipline and five plus years of related 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.
2+ years of prior hands-on experience reviewing data, documents, notebooks and worksheets generated in an analytical test laboratory (preferred).
Strong mathematical skills; ability to understand, review and check calculations used to perform analytical testing using various instruments in a GMP lab.
2-5 years of experience using laboratory instrument data acquisition software (Empower, Chemstation, Chromeleon, etc.).
Knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and compendial references (USP/Ph. Eur., etc.) as they apply to data/document review (preferred).
Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.).
Ability to communicate effectively with chemists by explaining deficiencies in the documentation and providing constructive feedback to minimize recurring errors.
Demonstrated ability to organize and prioritize work tasks and to work independently.
Employer Information System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One provides eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #568-Clinical
#J-18808-Ljbffr