Quality Assurance Auditor - marsqa

Quality Assurance Auditor - marsqa

  Quality Assurance Auditor QUALITY ASSOCIATES INC. has been providing regulatory services to the pharmaceutical, chemical, and agrochemical industri...

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Quality Assurance Auditor QUALITY ASSOCIATES INC. has been providing regulatory services to the pharmaceutical, chemical, and agrochemical industries since 1986. From our inception, Quality Assurance programs have been the cornerstone of QAI. QAI supports EPA, FDA, and OECD GLPs, FDA/ICH GCPs; and ANS/ISO/IEC 17025 Guidelines. QAI offers the following services: establishment of Quality Assurance programs, support of existing QA units, operation as the independent QAU, SOP development, and quality system training programs. Our main offices are located in Fulton, MD with additional offices in Delaware, Minnesota, and Ohio. For more details, please visit our web site at www.QualityAssociatesInc.com. QAI has an immediate opening in the Northern Delaware area. We are seeking one skilled and dependable individual as Quality Assurance Auditor. Quality Assurance Auditor Background requirements: BS or equivalent experience, with 2 years of quality assurance experience in good laboratory practices required. Hands on toxicology, histology, pathology or chemistry experience desired. Excellent writing and communication skills necessary. Demonstrated ability to work in a team. Job Responsibilities: The individual will apply technical knowledge to audit the activities of a toxicology laboratory, and review toxicology studies, including analytical chemistry and metabolism data, performed for submission to EPA and FDA. The individual will integrate technical knowledge with regulatory knowledge to review compliance with the applicable quality regulations. The individual will coordinate with laboratory management and study directors in scheduling all audits and in-phase study inspections. Occasional travel is expected to audit contract facilities. Duties will include • • • • •

technical review and audit of study data and reports protocol and in-phase audits preparation of audit reports, recommendations on findings, and review of responses laboratory and process inspections many other GLP required duties

QAI offers competitive salaries, excellent benefits, and supportive management. QAI is an Equal Opportunities Employer. Please contact Philippe Ourisson at [email protected]

8161 Maple Lawn Boulevard, Fulton, Maryland 20759 • (410) 884-9100 • Fax: (410) 884-9122