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 qa Auditor

Details
Country: USA
Location: New Jersey-Central Edison, NJ
Total applied: 45
qa Auditor

Qualifications Bachelor's degree in chemical, biology or a related scientific discipline plus 8 to 10 years of experience in a non-clinical laboratory. Master¿s degree preferred,  in all facets of EPA analytical, data validation, and QA/QC procedures. Specific emphasis on inorganic analyses required including AA, ICP, ICP-MS methods. Clear verbal and written communication skills are required.  2 years of laboratory supervisory or group leader experience is required. In some cases, educational requirements may be adjusted or waived for more than 15 years applicable work experience. Work experience may be adjusted for highly specialized knowledge or uniquely applicable experience for positions involving new technology or labor market shortages as reflected by market survey data. Responsibilities Will conduct technical review/validation of inorganic analysis data produced by various laboratories and prepare reports detailing the results of the review.  Data review shall comprise determinations of data quality for usability and shall be performed in accordance with established data validation procedures.  Will perform QA review of analytical operations and prepare reports of findings, recommend corrective actions, conduct follow-up compliance reviews, coordinate the external performance evaluation program, and prepare and update QA program policy documents. Leads other auditors to ensure good laboratory practices (GLP) in the conduct of highly complex non-clinical laboratory studies and work, including requirements of the Food and Drug Administration, the Environmental Protection Agency, and Alion¿s policies and procedures. Duties and Responsibilities Leads the review of all study protocols and conducts inspections to ensure that work being performed adheres to GLP, the protocol, and standard operating procedures. Leads audits of highly complex research reports for non-clinical laboratory studies and works in support of such studies. Notifies appropriate staff of findings at the conclusion of audits and inspections.  Makes recommendations to management to correct any deficiencies uncovered. Follows up on all audits and inspections to ensure that corrective actions have been implemented. Reports to management on actions taken. Coordinates the maintenance of the quality assurance archives and filing system. Makes recommendations to management to automate the quality assurance records system. Stays abreast of new developments in government requirements and recommends changes to management in policies and procedures to ensure compliance. Develops and presents reports, briefings, studies, or other information to management. Provides work leadership to less experienced Quality Assurance Auditors. Closing Statement

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