Senior Quality Assurance Auditor

Company Overview

Scientific Resources, an Offering of Doherty, has an exciting opportunity in Cincinnati, Ohio with a biopharmaceutical company that manufactures, markets, and distributes a broad range of innovative diagnostic test kits.

Job Summary

Support Quality Policy, company operating procedures, and provide cost effective solutions for success.  Individual will be actively involved with quality improvements and have a constant awareness of customer requirements.  The position requires metric driven decision making, accurate and concise record keeping, an awareness and upholding of 21 DFR, Part 820 and ISO 9000:2000, partnering with internal customers and supplier, progressive activity toward developing a meaningful career, supporting management decisions concerning growing the company's business strategy.

DutiesMonitor all activities relative to quality systems proficiency, testing, and data evaluation as well as those associated with company-wide equipment calibration/preventive maintenance and incoming goods. Manage the internal audit program.  Lead internal and external quality system audits Limited to moderate travel associated with training, corporate acquisitions, audits, and mergers. Other projects or duties assigned.

QualificationsRequires a two year degree, BS in a science or related field a must Completed training and experience in the auditing function Quality auditor certification (CQA) required Certifications Required21 CFR Part 820 EVD Directive 98/79/EC ISO 13485:2003

Specific SkillsStrong understanding of immunological principles and test methods (ELISA, IFA, Latex Agglutination). Strong attention to detail Familiarity with computer applications (MS Word, Excel, Access, SPC) Strong working knowledge of QSR and ISO Quality Systems Strong organization and communication skills Ability to make public presentations Ability to direct and manage subordinates' day to day activities as well as special projects to assure timely completion